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 2172 of 3531

510(k) clearances, page 2172 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934095	Ivac Vented Syringe Adapter Administration Sets	Y	FPA	Class II	1994-08-10
K943671	Gsi Cannula Reducer Accessory	General Surgical Innovations	GCJ	Class II	1994-08-09
K943489	Disposable Surgical Trocar	Applied Medical Resources Corp	GCJ	Class II	1994-08-09
K943395	Philips M38 Series	Philips Hearing Instruments Co.	ESD	Class I	1994-08-09
K943381	Laser Alignment Tool	Philips North America LLC	IWE	Class I	1994-08-09
K943337	Standup Wheelchair	Nestor Rehab Products, Ltd.	IPL	Class II	1994-08-09
K942841	Oec 901	Baldwin	JAA	Class II	1994-08-09
K942335	Aci Silicath Thoracic Catheter	American Catheter Corp	GBX	Class I	1994-08-09
K942189	Crystal Ear	Crystal Care Intl., Inc.	ESD	Class I	1994-08-09
K941325	Water Irrigator, W1 200	Strong Medical, Inc.	KHH	Class I	1994-08-09
K941219	Dupont Aca Plus Fsh/lh/prolactin Calibrator	Dupont Medical Products	JIX	Class II	1994-08-09
K941107	The Canal (C.i.c.) Aka/hidden Ear	Qualitone	ESD	Class I	1994-08-09
K940667	Starkey Ce-8 Tml, Starkey Ce-8 Tmc Air Conduction Hearing Aid	Starkey Laboratories, Inc.	ESD	Class I	1994-08-09
K940489	Simon Nitinol Filter	Nitinol Medical Technologies, Inc.	DTK	Class II	1994-08-09
K940178	Percor Stat-Dl 9.5 Fr.34cc & 40Cc /Percor Stat-Dl 10.5 Fr.40cc & 50Cc Intra-Aortic Balloon Modification	Datascope Corp.	DSP	Class II	1994-08-09
K935157	Articulated, Laparoscopic, and Side-Viewing T-Probes	Regulatory Consultants to the Medical Device Indus	KPX	Class II	1994-08-09
K935055	Roche Abuscreen Radioimmunoassay for Morphine (High Cut-Off)	Roche Diagnostic Systems, Inc.	DOE	Class II	1994-08-09
K934303	Rfa a-300	Scanditronix, Inc.	IYE	Class II	1994-08-09
K932208	Extracorporeal Circuit W/duraflo II Heparin Treatm	Baxter Healthcare Corporation	DWF	Class II	1994-08-09
K931785	Branemark System Drill Controller	Nobelpharma USA, Inc.	DZE	Class II	1994-08-09
K926321	Varian C/d-Series Clinacs (Clinac 600 C/d)	Varian Assoc., Inc.	IYE	Class II	1994-08-09
K923172	Anaesthesia Record Keeper	Datex Division Instrumentarium Corp.	BSZ	Class II	1994-08-09
K943008	Bioscan Reagent Strips	Genesis Labs, Inc.	JJB	Class I	1994-08-08
K942440	Afp Cardiac Pacing System Model 283	Siemens-Pacesetter, Inc.	DTB	Class III	1994-08-08
K942421	Implantech Lateral Mandibular Bar Implant	King & Spalding	LZK	Class II	1994-08-08
K942420	Implantech Midface-Submalar Le Fort Implant	King & Spalding	LZK	Class II	1994-08-08
K942358	Autoclaveable Medicam 900 Digicon Camera	M.P. Video, Inc.	GCJ	Class II	1994-08-08
K934827	Branemark System Estheticone Non-Rotational System	Nobelpharma USA, Inc.	DZE	Class II	1994-08-08
K934826	Branemark-Healing Caps, Dcc045, Dcc046, Dcc104	Nobelpharma USA, Inc.	DZE	Class II	1994-08-08
K934825	Branemark System	Nobelpharma USA, Inc.	DZE	Class II	1994-08-08
K934495	Branemark System(r) Ucla-Type Abutment Complete	Nobelpharma AB	DZE	Class II	1994-08-08
K921846	Oceania Health Care Systems Electronic Medical Rec	Oceania Health Care Systems, Inc.	LNX		1994-08-08
K943509	7300 Nasal CPAP System	Healthdyne Technologies, Inc.	BZD	Class II	1994-08-05
K943507	Wink Eyewear	Wink Optical, Inc.	HQZ	Class I	1994-08-05
K943491	Right Angle Urologic Laser Fiber	Surgitek	GEX	Class II	1994-08-05
K943352	Spoma International Corporation	Spoma Intl. Corp.	HQY	Class I	1994-08-05
K943265	N-Redwall, David Optics, Christian Liza, Dmo	The First Optical Manufactory, Ltd.	HQZ	Class I	1994-08-05
K943198	Spectacle Frames	Lunettes Folomi S.A.	HQZ	Class I	1994-08-05
K942972	Powder Free Vinyl Patient Examination Gloves	Lcl Taiwan & Co., Ltd.	LYZ	Class I	1994-08-05
K942897	Opthalmic Wipe	Surgin Surgical Instrumentation, Inc.	HQZ	Class I	1994-08-05
K942814	Self Super Maxi Snaitary Napkins	Kegan & Kegan, Ltd.	HHD	Class I	1994-08-05
K942754	Sunglasses	Kimball Corp.	HQY	Class I	1994-08-05
K942721	Neitz Halogen Ophthalmoscope Bxa-13	Neitz Instruments Company, Ltd.	HLJ	Class II	1994-08-05
K942720	Neitz Halogen Ophthalmoscope Bxa-12	Neitz Instruments Company, Ltd.	HLI	Class II	1994-08-05
K942719	Neitz Halogen Pocket Ophthalmoscope a-Jr	Neitz Instruments Company, Ltd.	HLJ	Class II	1994-08-05
K942717	Neitz Halogen Ophthalmoscope Bxa-13A	Neitz Instruments Company, Ltd.	HLJ	Class II	1994-08-05
K942715	Neitz Halogen Ophthalmoscope Bxa-Rc	Neitz Instruments Company, Ltd.	HLI	Class II	1994-08-05
K942714	Neitz Halogen Ophthalmoscope Bxa-Rp	Neitz Instruments Company, Ltd.	HLI	Class II	1994-08-05
K942713	Neitz Halogen Binocular Indirect Ophthalmoscope Io-H	Neitz Instruments Company, Ltd.	HLI	Class II	1994-08-05
K942712	Neitz Halogen Binocular Indirect Ophthalmoscope Io-a	Neitz Instruments Company, Ltd.	HLI	Class II	1994-08-05