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 2169 of 3531

510(k) clearances, page 2169 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943822	Fuji Um Mammo Series Intensify Screens:	FUJIFILM Healthcare Americas Corporation	EAM	Class I	1994-08-22
K943821	Kyokko Spec-Series Intensify Screens-Spec,super Spec	FUJIFILM Healthcare Americas Corporation	EAM	Class I	1994-08-22
K943758	Surgical Bur	Komet Medical	GFF	Class I	1994-08-22
K943706	Audilens Llk	Widex Hearing Aid Co., Inc.	ESD	Class I	1994-08-22
K943693	Pulsemaster S Series	Incisive Technologies Pty Ltd	GEX	Class II	1994-08-22
K943652	Vascular Mp X-Ray Generator	GE Healthcare	IZO	Class I	1994-08-22
K943090	Suture Removal Trays	Sterile Concepts, Inc.	FRG	Class II	1994-08-22
K942885	Auto Suture Modified Grip	United States Surgical, A Division of Tyco Healthc	FBQ	Class II	1994-08-22
K942857	Siemens Bte Hearing Aids	Siemens Hearing Instruments, Inc.	ESD	Class I	1994-08-22
K942794	Hygrolife	Mallinckrodt Medical	BYD	Class I	1994-08-22
K942392	Airway Connector with Flex Tube	Mallinckrodt Medical	BZA	Class I	1994-08-22
K942383	Dermiview Clear Tape	Johnson & Johnson International	KGX	Class I	1994-08-22
K942382	Ms Amplatz Extra Stiff Guide Wire	Meadox Surgimed, Inc.	DQX	Class II	1994-08-22
K940295	Uroview Model 2600	GE Dec Medical Systems	JAA	Class II	1994-08-22
K935721	Stone Extractor	Boston Scientific Corporation	FFL	Class II	1994-08-22
K934318	Diagnostic Instrumlents Inc. Model T803 Breast Coil	Diagnostic Instrument Corp.	LNH	Class II	1994-08-22
K943619	Cavi-Care Conforming Foam Dressing	Smith & Nephew United, Inc.	KMF	Class I	1994-08-19
K943402	K.p.r. (King Personal Resuscitator)	King Systems Corporation.	CBP	Class II	1994-08-19
K943293	Scc22/ Scc26 Shower Commode Chair	O'Tec Corp.	IOR	Class I	1994-08-19
K943229	Disposable Surgical Scissors and Forceps	Y.M.K. International Co., Ltd.	KDC	Class I	1994-08-19
K943110	Gas Sampling Interfaces	Coast Medical Corp.	BYX	Class I	1994-08-19
K942703	Gm Reusable and Disposable Trocar and Gm Reusable and Disposable Ultra-Light Cannula	Gm Engineering, Inc.	GCJ	Class II	1994-08-19
K942578	Entrac Ureteral Balloon Dilatation Catheters	American Medical Systems, Inc.	EZN	Class II	1994-08-19
K942412	Therex Low-Profile Port - Titanium Model	Therex Corp.	LJT	Class II	1994-08-19
K936071	Smith & Nephew Dyonics Inc. Electronic Endoscope	Smith & Nephew Dyonics, Inc.	HET	Class II	1994-08-19
K935862	Northgate Technologies Omniflator Model 6600	Northgate Technologies Inc.	HIF	Class II	1994-08-19
K935045	Biosearch Laproscopic Gastronomy Catheter	Biosearch Medical Products, Inc.	KNT	Class II	1994-08-19
K931322	Ks 5 - Clinical Audiometer	Maico Hearing Instruments, Inc.	EWO	Class II	1994-08-19
K931131	The Richards Wrist	Smith & Nephew Richards, Inc.	JWJ	Class II	1994-08-19
K920780	Medsurg Insertion Tray	Medsurg Industries, Inc.	LFJ	Class II	1994-08-19
K943670	Mo6 Series	Philips Hearing Instruments Co.	ESD	Class I	1994-08-18
K943667	Esophagoscope and Accessories	Karl Storz Endoscopy-America, Inc.	EOX	Class II	1994-08-18
K943280	Procel Burn Cover/procel Burn Treatment Cover	W.L. Gore & Company, GmbH	MGP	Unclassified	1994-08-18
K942629	Nce Replacement Batteries	National Custom Ent., Inc.	DPS	Class II	1994-08-18
K942628	Esophageal Intubation Detector Bulb	Wolfe Tory Medical, Inc.	BTR	Class II	1994-08-18
K942241	Dupont Apc Blood Collection Container with Thromboplastin	Dupont Medical Products	JKA	Class II	1994-08-18
K942154	Schneider Total Cross and Match 35 Percutanewous Transluminal Angioplasty Catheters	Boston Scientific Corporation	LIT	Class II	1994-08-18
K941983	Sealite Sciences Inc.	Sealite Sciences, Inc.	DHA	Class II	1994-08-18
K941614	Axsym Tobramycin	Abbott Medical	LFW	Class II	1994-08-18
K941328	Trak Liquid Cerebrospinal Fluid Control Levels 1 & 2	Medical Analysis Systems, Inc.	JJY	Class I	1994-08-18
K941227	Shortwave Epilator for Permanent Hair Removal	Instantron	KCW	Class I	1994-08-18
K941037	Bnos Micro Vent, Model Ac and Model Ao	Reeves Manufactoring	BTM	Class II	1994-08-18
K941026	Thayer Mask to Mouthpiece Adapter/connector	Thayer Medical Corportation	BZA	Class I	1994-08-18
K940984	Cardiometrics Dualflow Switch Box	Cardio Metrics, Inc.	DQX	Class II	1994-08-18
K940838	Microvasive Ultraflex Esophageal Stent System	Boston Scientific Corporation	ESW	Class II	1994-08-18
K940799	Flexguide	Scientific Sales Intl., Inc.	BSR	Class I	1994-08-18
K940518	C-Section Tray	Cush Medical Products	MLS	Class II	1994-08-18
K935193	Consensus Hip System- Porous Coated Titianium Femoral Stem	U.S. Medical Products, Inc.	LZO	Class II	1994-08-18
K934093	580Cdr Display Driver	Vidco, Inc.	DXJ	Class II	1994-08-18
K910318	Bard(r) Hydrogel/silver-Coated Foley Catheter	C.R. Bard Inc	MJC	Class II	1994-08-18