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 1738 of 3531

510(k) clearances, page 1738 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K991212	Modification to Truzone Peak Flow Meter	Monaghan Medical Corp.	BZH	Class II	1999-07-01
K991177	Opus Troponin I (Ctn) Test Modules	Siemens Healthcare Diagnostics Inc.	MMI	Class II	1999-07-01
K991176	Opus Troponin I Calibrator	Siemens Healthcare Diagnostics Inc.	JIT	Class II	1999-07-01
K991169	Sx 53/15-Bp, Model 124 853, Sx 60/15-Bp, Model 124 854	BIOTRONIK AG	DTB	Class III	1999-07-01
K991122	Cryo-Mono Cryogrnic System	Influence, Inc.	GEH	Class II	1999-07-01
K990965	Synthes Cervifix System	Synthes (USA) Products LLC	KWP	Class II	1999-07-01
K990602	Richter Lipoplasty Cannulas and Accessories	Tecsa Technical Services	QPB	Class II	1999-07-01
K990496	Anesflow-Dual Drip IV Infusion Set	Innovative Design Assoc.	FPA	Class II	1999-07-01
K990454	Bio-Interference Screw	Innovasive Devices, Inc.	HWC	Class II	1999-07-01
K984640	Thermal Angel	Estill Medical Technologies, Inc	BSB	Class II	1999-07-01
K983837	Hedrocel Acetabular Cage System	Implex Corp.	LPH	Class II	1999-07-01
K983631	Auto-PEEP Measurement Device, Model # Kc 9-P	Instrumentation Industries, Incorporated	CBP	Class II	1999-07-01
K992033	Modification to 'Rapid Drug Screen' 9-Panel	American Bio Medica Corp.	DKZ	Class II	1999-06-30
K991666	Tibc, Product No's 123-0, 123-02, Fe109-01, Fe109-02	A.P. Total Care, Inc.	JMO	Class I	1999-06-30
K991663	Ast/sgot	A.P. Total Care, Inc.	CIT	Class II	1999-06-30
K991582	Chiron Diagnostics Acs: 180 Folate	Chiron Diagnostics Corp.	CGN	Class II	1999-06-30
K991576	Additional Assays for the Bayer Advia 1650 Chemistry System	Bayer Corp.	CIX	Class II	1999-06-30
K991282	Colorpoint 1720 Medical Imagers and Video Capture Box Cx-1000 Series	Seiko Instruments USA, Inc.	LMC	Class II	1999-06-30
K991242	Glucometer Elite Test Strips	Bayer Corp.	CGA	Class II	1999-06-30
K991098	Difoti System	Electro-Optical Sciences, Inc.	EIA	Class I	1999-06-30
K990461	Mckinley Sp Disposable Infusion Pump	Mckinley, Inc.	MEB	Class II	1999-06-30
K992010	W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear) and Horizon 55 Westint (Tinted)	Westcon Contact Lens Co., Inc.	LPL	Class II	1999-06-29
K991952	Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts	Howmedica Osteonics Corp	LZO	Class II	1999-06-29
K991781	Fluorex Ultra (Flusilfocon E) Rigid Gas Permeable Contact Lens	G.T. Laboratories, Inc.	HQD	Class II	1999-06-29
K991780	Fluorex 700 -UV (Flusilfocon a), Fluorex 500-UV (Flusilfocon B) and Fluorex 300-UV (Flusilfocon C) Rigid Gas Permeable C	G.T. Laboratories, Inc.	HQD	Class II	1999-06-29
K991603	Grit Blasted Humeral Stem	Encore Orthopedics, Inc.	KWT	Class II	1999-06-29
K991595	Oribrush - with Protective Tip - B001	Orifice Medical AB	HHT	Class II	1999-06-29
K991593	Oribrush - Standard - B002	Orifice Medical AB	HHT	Class II	1999-06-29
K991405	Omni-Fix, Humeral Nail	Turnkey Intergration USA, Inc.	KTW	Class II	1999-06-29
K991314	Coaguloop	American Medical Systems, Inc.	FAS	Class II	1999-06-29
K991287	Spyrogel Hydrogel Wound and Burn Dressing Sa	Advanced Medical Solutions Group PLC	FRO	Unclassified	1999-06-29
K991229	K-Systems Work Stations, Type L-13W, L-13E, L-13Es, L-13Et, L-13Em, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,l	Henning Knudsen Engineering A/S	MQG	Class II	1999-06-29
K991118	O.b. Applicator Tampons, O.b. Tampons	Personal Products Co.	HEB	Class II	1999-06-29
K991107	Shadow Trays	Mick Radio-Nuclear Instruments, Inc.	IYE	Class II	1999-06-29
K990628	Gyrus Endourology System	Gyrus ACMI, Inc.	KNS	Class II	1999-06-29
K990198	Amib7	Alliance Medical Corp.	IYO	Class II	1999-06-29
K984586	Fresenius Atr40 and Atr120 Autotransfusion Reservoirs	Fresenius Hemotechnology, Inc.	DTN	Class II	1999-06-29
K991987	Color Buffed Answer Cemented Femoral	Zimmer GmbH	JDI	Class II	1999-06-28
K991234	The Acme Medical Aesthetic Nd:yag Laser	Acme Medical, Inc.	GEX	Class II	1999-06-28
K991061	Dermaphylyx Calcium Alginate Wound Dressing	Dermaphylyx, Inc.	NAE	Class I	1999-06-28
K991000	Gentle Touch UV (Netrafilcon a) Soft Contact Lenses	Wesley Jessen Corp.	LPL	Class II	1999-06-28
K990998	Polyslit Ife Kit	Helena Laboratories, Corp.	CFF	Class II	1999-06-28
K990705	Medamicus Coaxial Introducer Kit, 10330-Xxx, Boston Scientific Coaxial Dilator Set	Greatbatch Medical	DYB	Class II	1999-06-28
K990280	Bionike Aq Barbiturate Test	Bionike, Inc.	DIS	Class II	1999-06-28
K990057	Synergy Adjustable Length Rod	Interpore Cross Intl.	MNI	Class II	1999-06-28
K984162	Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use	Nobelpharma USA, Inc.	MAH	Class II	1999-06-28
K983497	Overlander Pev 2000	Raye'S, Inc.	ITI	Class II	1999-06-27
K991928	Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders & Dissectors	Medtronic, Inc.	GCJ	Class II	1999-06-25
K991843	Greiner Minicollect Lithium Heparin Gel Blood Collection Tube	Greiner Meditech, Inc.	JKA	Class II	1999-06-25
K991793	Angiodynamics Balloon Expandable Biliary Stent System	Boston Scientific Corporation	FGE	Class II	1999-06-25