Regulatory Technology Services

Regulatory Technology Services (RTS) is the #1 FDA Accredited Third Party 510k Review Organization to perform 510(k) reviews under the FDA’s Accredited Persons Program (3P510k).

Since our inception, RTS engineers, scientists, and clinicians have reviewed over 1,500 submissions averaging 10-14 days from receipt of submission to completion of substantive review.

RTS is the leading and longest serving FDA Accredited 3P510k Review Organization reviewing over 70% of all reviews completed by Third Party Organizations, year after year. In business since 2003, RTS has reviewed and cleared over 1,500 510(k) submissions. RTS has a highly qualified team of reviewers with the scientific, technical and regulatory expertise to review a broad range of Class I and Class II medical devices. RTS is also the only FDA Accredited 3P510k Review Organization that has the eligibility to review medical devices in all twenty of the Medical Specialties / Review Panels listed on the FDA List of Devices for 3P510k Third Party Review (go.usa.gov/xVUX7).

One of the key drivers cited by the FDA for creating the FDA 3P510k Accredited Persons Program is "enhanced speed to market" and no organization embraces this ideal better than RTS. Our unparalleled speed and experience assures you the fastest turnaround time for your eligible 510(k) product review and clearance. We are routinely months faster reviewing and clearing 510(k) submissions versus the FDA, with administrative review completed in 24 hours and substantive review completed in 10-14 days.

Recent Clearances - Updated as of April 29, 2023

Alliage S/A Industrias Medica Odontológico. | Eagle S/Saevo Slim/D700 Slim
Device Classification Name: system, x-ray, extraoral source, digital
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230732

Sprig Oral Health Technologies, Inc. | SmartMTA Capsule
Device Classification Name: resin, root canal filling
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230797

CyMedica Orthopedics, Inc. | Motive™ Electrode
Device Classification Name: electrode, cutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230533

Siemens Healthcare GmBH | Syngo Carbon Space VA30A
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230561

ALG Health LLC | Savvy Surgical Mask - Level 3
Device Classification Name: mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230383

Siemens Medical Solutions USA, Inc. | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230207

Siemens Healthcare GmBH | syngo.via View&GO VA40A
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230196

Nephron Pharmaceuticals Corporation | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
Device Classification Name: polymer patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223559

Philips Ultrasound LLC | PercuNav Image Fusion and Interventional Navigation System
Device Classification Name: system, x-ray, tomography, computed
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223804

3M ESPE Dental Products | 3M™ VitCal Liner/Base
Device Classification Name: liner, cavity, calcium hydroxide
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230270

Atomica Technology, Inc. | Atomica Planner
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230012

Qingdao Yasee Medical Device Co., Ltd. | Electronic Sphygmomanometers
Device Classification Name: system, measurement, blood-pressure, non-invasive
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222394

Mima-Pro Scientific Inc. | SurBlate Ablation System
Device Classification Name: system, ablation, microwave and accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223272

US Medical Glove Company LLC | Nitrile Exam Gloves (Chemotherapy Drug Tested)
Device Classification Name: polymer patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223748

TECHFIT Digital Surgery Inc. | TECHFIT Diagnostic Models
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222577

Solta Medical, Inc. | CLEAR+BRILLIANT TOUCH® Laser System
Device Classification Name: powered laser surgical instrument
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223647

Fuji Systems Corporation | CELLO II Balloon Guide Catheter
Device Classification Name: catheter, percutaneous, neurovasculature
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223275

Premier Dental Products Company | Premier's MultiMatch Universal Chameleon Restorative Composite
Device Classification Name: material, tooth shade, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223632

phenox Ltd | pNOVUS 21 Microcatheter
Device Classification Name: catheter, intravascular, diagnostic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221279

America’s Supply Chains | High Fluid-Resistant Surgical and Procedure Mask
Device Classification Name: mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222749

SafeSource Direct, LLC | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
Device Classification Name: polymer patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222898

Aquilo Sports LLC | Aquilo Sports CCT1500 System
Device Classification Name: massager, powered inflatable tube
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223164

America's Supply Chains | POSE™ Health Care Surgical Mask
Device Classification Name: mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223270

Philips Ultrasound LLC | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222648

DETAX GmbH | FREEPRINT crown
Device Classification Name: material, tooth shade, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222877

Lamidey Noury Medical | MCB UNIT Model: V10GMCBUS
Device Classification Name: unit, electrosurgical, endoscopic (with or without accessories)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222542

LightForce Orthodontics | LightForce Orthodontic System
Device Classification Name: bracket, ceramic, orthodontic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222764

Shanghai Kindly Medical Instruments Co., Ltd | INT Introducer Set
Device Classification Name: introducer, catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222647

The list above is not all-inclusive. All devices reviewed by RTS are listed on the FDA website.