510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2249 of 3531

510(k) clearances, page 2249 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931660	Ultrabronz Series 400 Tanning Bed	Eurocut, Ltd.	LEJ	Class II	1993-12-17
K931614	Mopylen Suture	S. Jackson, Inc.	GAW	Class II	1993-12-17
K931613	Supramid Suture	S. Jackson, Inc.	GAR	Class II	1993-12-17
K931612	Nylamid Suture	S. Jackson, Inc.	GAR	Class II	1993-12-17
K930992	Flexon and Stainless Steel Sutures	American Cyanamid Co.	GAQ	Class II	1993-12-17
K930945	Braided Polyester Surgical Suture	Lukens Medical Corp.	GAT	Class II	1993-12-17
K930944	Lukens Surgical Gut Suture	Lukens Medical Corp.	GAL	Class II	1993-12-17
K930943	Lukens Nylon Surgical Suture	Lukens Medical Corp.	GAR	Class II	1993-12-17
K930942	Lukens Silk Surgical Suture	Lukens Medical Corp.	GAT	Class II	1993-12-17
K930941	Lukens Polypropylene Monofilament Nonabsorbable	Lukens Medical Corp.	GAW	Class II	1993-12-17
K930940	Lukens Stainless Steel Surgical Suture	Lukens Medical Corp.	GAQ	Class II	1993-12-17
K930591	Ti-Cron and Dacron Sutures	Davis & Geck, Inc.	GAT	Class II	1993-12-17
K930590	Silk Sutures	Davis & Geck, Inc.	GAT	Class II	1993-12-17
K930589	Plain, Mild Chromic and Chromic Surgical Gut Sutur	Davis & Geck, Inc.	GAL	Class II	1993-12-17
K930587	Surgilene Polypropylene Suture	Davis & Geck, Inc.	GAW	Class II	1993-12-17
K930586	Dermalon,surgilon,ophthalon,& Ophthalmic Nylon Sut	Davis & Geck, Inc.	GAR	Class II	1993-12-17
K930517	Non-Absorbable Surgical Sutures	Alcon Laboratories	GAR	Class II	1993-12-17
K930360	Sutures	Ethicon, Inc	GAM	Class II	1993-12-17
K926588	Revised Labeling for Polypropylene Suture	Look, Inc.	GAW	Class II	1993-12-17
K926587	Revised Labeling for Nylon Suture (Polyamide)	Look, Inc.	GAR	Class II	1993-12-17
K926181	Zsi Laparoscopes-General & Plastic Surgery	Zinnanti Surgical Instruments, Inc.	GCJ	Class II	1993-12-17
K926168	Silk Sutures-Revised Labeling	Look, Inc.	GAR	Class II	1993-12-17
K926167	Polyviolene Suture-Revised Labeling	Look, Inc.	GAT	Class II	1993-12-17
K921309	Model 508 Patient Monitor	Criticare Systems, Inc.	BTY	Class II	1993-12-17
K935674	Lifepak 9 Defibrillator/monitor	Physio Control, Inc.	LDD	Class II	1993-12-16
K935177	Gamma-Glutamyl Transferase (Ggt) Test	Em Diagnostic Systems, Inc.	JQB	Class I	1993-12-16
K935176	Iron Test	Em Diagnostic Systems, Inc.	JIY	Class I	1993-12-16
K935175	Lactate Dehydrogenase (Ld)	Em Diagnostic Systems, Inc.	CFJ	Class II	1993-12-16
K935174	Total Protein Test (Tpro)	Em Diagnostic Systems, Inc.	CEK	Class II	1993-12-16
K935136	Cholesterol (Chol) Test Item No. 65410	Em Diagnostic Systems, Inc.	CHH	Class I	1993-12-16
K934808	Uvisol and Uvisol II	National Biological Corp.	FTC	Class II	1993-12-16
K934602	Acs.018 Hi-Torque Floppy Guide Wire - Acs Hi-Torque Floppy Extra Support Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1993-12-16
K934185	Trocar Reducer with Gas Clheck Valve	Phx Technologies Corp.	GCJ	Class II	1993-12-16
K934098	Sterile, Disposable Endoscopic Trumpet Valve	Phx Technologies Corp.	GCJ	Class II	1993-12-16
K934084	Bioenterics Endolumina Illuminating Bougie	Bioenterics Corp.	HMJ	Class I	1993-12-16
K932899	Classique	Hemispheres Marketing Co., Ltd.	KCZ	Class I	1993-12-16
K932083	Xdcs-100	Microwave Medical Systems, Inc.	DXT	Class II	1993-12-16
K931487	Bld Heated Breathing Circuit W/exhalation Valve	Bird Life Design	CAI	Class I	1993-12-16
K931202	Sterilization Wrap-Sterisheet	Arjo Wiggins Medical, Inc.	FRG	Class II	1993-12-16
K930669	Atrium Polypropylene Mesh	Atrium Medical Corporation	FTL	Class II	1993-12-16
K926219	516Yt Display Driver	Vidco, Inc.	DXJ	Class II	1993-12-16
K924109	Steerocath II	Ep Technologies, Inc.	DRF	Class II	1993-12-16
K924108	Tracfinder II	Ep Technologies, Inc.	DRF	Class II	1993-12-16
K935420	Soundright, Shp	Soundright Hearing Products	ESD	Class I	1993-12-15
K935397	Nuclear Associates Knight Sr., Knight Jr. and Sesam Portable Radiography Cassette Holders	Victoreen, Inc.	IXA	Class II	1993-12-15
K935266	Miracle Ear Model Sharp II Micro Canal Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1993-12-15
K935265	Miracle Ear Model Sharp II Canal	Miracle-Ear, Inc.	ESD	Class I	1993-12-15
K935095	8260 Series 3M Programmable Hearing Instruments	3M Company	ESD	Class I	1993-12-15
K934944	Mpq-42	Elema-Schonander, Inc.	IZP	Class II	1993-12-15
K934646	Action Wizard Pediatric Manual Wheelchair	Invacare GmbH	IOR	Class I	1993-12-15