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 1767 of 3531

510(k) clearances, page 1767 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990125	Hp Viridia Component Monitoring System, Model Rev. K	Hewlett-Packard Co.	DSI	Class II	1999-01-29
K990092	Avl Omni Modular Analyzer	Avl Scientific Corp.	CHL	Class II	1999-01-29
K990026	Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	1999-01-29
K984626	Architect B12 Masterchek, Model # 6C09-O5	Bio-Rad	JJX	Class I	1999-01-29
K984481	Exhalation Valve	Intersurgical Ltd.	CBP	Class II	1999-01-29
K984477	Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529	Bio-Rad	JJY	Class I	1999-01-29
K984402	Synchron Systems Ammonia (Amm) Reagent	Siemens Healthcare Diagnostics Inc.	JIF	Class I	1999-01-29
K984369	Dci Endoscope	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1999-01-29
K984152	Synchron Systems Opiates 2000 Ng (Op2) Reagent	Siemens Healthcare Diagnostics Inc.	DJG	Class II	1999-01-29
K984055	Clinicath Polyflow Polyurethane Peripherally Inserted Catheters	Sims Deltec, Inc.	FOZ	Class II	1999-01-29
K983966	Nupro Prophylaxis Paste with Flouride and Triclosan	Dentsply Intl.	EJR	Class I	1999-01-29
K983915	Amplaid A315 and A319	Amplifon	EWO	Class II	1999-01-29
K983900	Venometer	Advanced Medical Technology, Inc.	JOM	Class II	1999-01-29
K983885	Burr Hole Covers, Craniomaxillofacial Plates	Howmedica Corp.	JEY	Class II	1999-01-29
K983878	Czaja-Mccaffrey Rigid Stent Introducer/endoscope	E. Benson Hood Laboratories, Inc.	EOQ	Class II	1999-01-29
K983868	Opmi Twiner Surgical Microscope	Carl Zeiss, Inc.	GEX	Class II	1999-01-29
K983858	Spinal Anesthesia Needles and Introducer Needles	Abbott Medical	MIA	Class II	1999-01-29
K983674	Vitros Immunodiagnostic Products: Ntx Calibrators, Ntx Reagent Pack, Ntx Controls	Ortho-Clinical Diagnostics, Inc.	JMM	Class I	1999-01-29
K983289	Apolipoprotein A1	Abbott Medical	DER	Class II	1999-01-29
K983029	Power Plus 25K Model, S1000, Power Plus 30K Model,s1001	TPC Advanced Technology, Inc.	ELC	Class II	1999-01-29
K982947	Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens	Ocular Sciences Puerto Rico, Inc.	LPL	Class II	1999-01-29
K982346	Angiodynamics Angiostent Biliary Stent System	Boston Scientific Corporation	FGE	Class II	1999-01-29
K982328	Bayer Advia Ims System (in Vitro Diagnostic System)	Bayer Corp.	CJO	Class II	1999-01-29
K990162	Abbott Liquid Ammonia Control, Model #'S 1E93-01,1E94-01,1E95-01	Bio-Rad	JJX	Class I	1999-01-28
K990161	Abbott Liquid Csf Control, Model #'S 1E98-01, 1E99-01	Bio-Rad	JJY	Class I	1999-01-28
K990059	Osteonics Spinal System-Expanded Indications	Howmedica Osteonics Corp	MNI	Class II	1999-01-28
K984529	Hemochek Sample Collection Kit	Osborn Laboratories, Inc.	LCP	Class II	1999-01-28
K984459	Depuy Profile Femoral Hip with Porocoat	Depuy Orthopaedics Inc.	LPH	Class II	1999-01-28
K984448	Bircoll Balloon Dissector	Wells Johnson Co.	FZW	Class I	1999-01-28
K984367	Activx	Adorno Rogers Technology	IOR	Class I	1999-01-28
K984354	Mechanical Wheelchair	Colours 'N Motion	IOR	Class I	1999-01-28
K984320	Bioabsorbable Interference Screws	Smith & Nephew, Inc.	HWC	Class II	1999-01-28
K984303	Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent	Ortho-Clinical Diagnostics, Inc.	LBR	Class I	1999-01-28
K984158	P.f.c. Modular Plus Offset Tibial Tray	Depuy, Inc.	JWH	Class II	1999-01-28
K984137	Quanta Lite Celiac Screen (Tissue Transglutaminase/gliadin) Elisa	Inova Diagnostics, Inc.	MVM	Class II	1999-01-28
K984132	Immulite C-Reactive Protein, Models Lkc1, Lkc5	Siemens Healthcare Diagnostics Inc.	DCK	Class II	1999-01-28
K984113	Ms400	Lsi Intl., Inc.	IPF	Class II	1999-01-28
K984107	Rdi Direct Ldl Cholesterol Test	Reference Diagnostics, Inc.	MRR	Class I	1999-01-28
K984082	Burn-Aid Hydrogel, Burn-Aid Burn Dressing, Burn-Aid Burn Blanket	Emox 911 CC	MGQ	Unclassified	1999-01-28
K984021	Ms300	Lsi Intl., Inc.	IPF	Class II	1999-01-28
K983852	Blue Value Line of Electrosurgical Electrodes, Model #'S 421-429	Geiger Medical Technologies, Inc.	GEI	Class II	1999-01-28
K983851	Capella Cochlear Emissions Analyzer	Madsen Electronics, Inc.	EWO	Class II	1999-01-28
K983774	Ualb	Abbott Medical	JIR	Class I	1999-01-28
K983655	Autostat II Ana Screen Elisa	Cogent Diagnotics, Ltd.	LJM	Class II	1999-01-28
K983592	Sulzer Orthopedics Sysorb Interference Screws	Sulzer Orthopedics, Inc.	HWC	Class II	1999-01-28
K983560	Innovasive Devices Intratunnel Tibial Fixation Fastener	Innovasive Devices, Inc.	MBI	Class II	1999-01-28
K982634	Dryspot Infectious Mononucleosis Kit	Oxoid, Ltd.	KTN	Class II	1999-01-28
K982493	Compeed Psoriasis Dressing	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	1999-01-28
K981729	Is-Rubella Igg Test System	Diamedix Corp.	LFX	Class II	1999-01-28
K981676	Cd Horizon Spinal System	Sofamor Danek USA,Inc.	KWP	Class II	1999-01-28