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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2811 of 3530

510(k) clearances, page 2811 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K871254	Acculevel Carbamazepine Test	Syva Co.	KLT	Class II	1987-06-17
K870731	Lyfo Kwik(tm) Rus Kit	Micro-Bio-Logics	JXA	Class I	1987-06-17
K862121	E.w.l. P-Tens/h-Wave	Electronic Waveform Laboratory, Inc.	KZM	Class II	1987-06-17
K871917	Frastec Dry Gauze Bandage	Fraass Survival Systems, Inc.	EFQ	Unclassified	1987-06-16
K871916	Frastec Dry Burn Dressing	Fraass Survival Systems, Inc.	EFQ	Unclassified	1987-06-16
K871900	Over Drape Leg Holder	Avec Scientific Design Corp.	KQZ	Class I	1987-06-16
K871549	Resub. Urine Cocaine Meta. Direct Ria Kit [I-125]	Immunalysis Corporation	KLN	Class II	1987-06-16
K871166	Allevyn Hydrophilic Polyurethane Dressing	Smith & Nephew, Inc.	NAD	Class I	1987-06-16
K871021	Guiding Catheters 9F Jl4	Devices for Vascular Intervention, Inc.	DQO	Class II	1987-06-16
K870515	Dynatron 438	Henley Intl.	IPF	Class II	1987-06-16
K870375	Model 617 Cardiac Output Computer	Omnimed B.V.	DXG	Class II	1987-06-16
K864614	Lp-3 Electrocardiograph	Fidelity Medical, Inc.	DPS	Class II	1987-06-16
K872140	(Msi) Path-Saver	Medical Specialties Inc.	IFP	Class I	1987-06-15
K872135	Mcbride Medium Cm 819	Oxoid U.S.A., Inc.	JSJ	Class I	1987-06-15
K872086	Acusyst-Jr	Endotronics, Inc.	KJH	Class I	1987-06-15
K872081	Cipro (Tm) Diagnostic Powder	Miles Pharmaceuticals	JTT	Class II	1987-06-15
K872080	Raichem(tm) Spia(tm) Apo B Reagents	Reagents Applications, Inc.	DFC	Class II	1987-06-15
K872079	Raichem(tm) Spia(tm) Apo a-1 Reagents	Reagents Applications, Inc.	MSJ	Class I	1987-06-15
K872076	Corning Disposable Roller Bottles	Corning Medical & Scientific	KJB	Class I	1987-06-15
K872056	Modified (Directions for Use) for Ideia(tm) Test	Boots-Celltech Diagnostics, Inc.	LJC	Class I	1987-06-15
K872001	Model Tpc-1A Oxygen Analyzer	Medical, Inc.	CCL	Class II	1987-06-15
K871985	Bear Jet Ventilator for Use During (Eswl)	Bear Medical Systems, Inc.	CBK	Class II	1987-06-15
K871949	Mmg Delee Suction Catheter W/mucous Trap	Medical Technologies of Georgia	BSY	Class I	1987-06-15
K871896	Tina-Quant [a] Transferrin	Boehringer Mannheim Corp.	DDG	Class II	1987-06-15
K871895	Tina-Quant [a] Crp	Boehringer Mannheim Corp.	DCK	Class II	1987-06-15
K871829	Siemens Dry Air Compressor	Siemens Elema AB	BTI	Class II	1987-06-15
K871742	Modified Use of Plex Inspiratory Muscle Trainer	Health Products, Inc.	BWF	Class II	1987-06-15
K871732	Churchill-H Vented IV Set W/metering Chambers	Churchill Corp.	FPA	Class II	1987-06-15
K871698	Resubmission of Urine Heroin/morphine Kit [I-125]	Immunalysis Corporation	DJG	Class II	1987-06-15
K871673	Nasopharyngeal Airway	Harding Industries, Inc.	BTQ	Class I	1987-06-15
K871661	Wh150 Room Humidifier	Associated Mills, Inc.	KFZ	Class I	1987-06-15
K871596	Ionescu-Shiley Pericardial Xenograft (Isu)	Shiley, Inc.	DTJ	Class I	1987-06-15
K871407	Meconium Aspirator	Intertech Resources, Inc.	BSY	Class I	1987-06-15
K871263	Multiple Pharma-Plast Tracheal Tube	Pharma-Plast USA, Inc.	BTR	Class II	1987-06-15
K871253	Masstron/marquest Mt-1000 Gas Analyzer	Masstron C/O Burditt, Bowles & Radzius, Ltd.	CCK	Class II	1987-06-15
K871086	IV Pump Set	Churchill Corp.	FPA	Class II	1987-06-15
K871085	Extension Tube Pump Set	Churchill Corp.	FPK	Class II	1987-06-15
K870719	Sensir System	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1987-06-15
K870330	Sp55 Syringe Pump	Vickers, Ltd.	FRN	Class II	1987-06-15
K872128	K-Gel	Taro Pharmaceuticals, Inc.	KMJ	Class I	1987-06-12
K872062	Eyedentity Eyewear	Vitech Research C/O Johnsen, Manfredi & Thorpe	HQZ	Class I	1987-06-12
K871940	Qm300 Iga, Antigen, Antiserum, Control	Kallestad Diag, A Div. of Erbamont, Inc.	CZP	Class II	1987-06-12
K871939	Qm300 C3 Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	CZW	Class II	1987-06-12
K871890	Cardio-Mega System	Grandcor Medical Systems	DSI	Class II	1987-06-12
K871685	Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt Sys	American V. Mueller	JXG	Class II	1987-06-12
K871604	Mvs 19 and Mvs 20 Gauge Scleral Plugs	Advanced Surgical Products, Inc.	LXP	Class II	1987-06-12
K871599	Delfia(tm) Hige Kit	Lkb Instruments, Inc.	DHB	Class II	1987-06-12
K871489	Dsl 5400 Active (Tm) Ferritin Eia System	Diagnostic Systems Laboratories, Inc.	DBF	Class II	1987-06-12
K871488	Vas-Cath Permanent Dual Lumen Hemodialysis Cath	Vas-Cath of Canada, Ltd.	LFJ	Class II	1987-06-12
K871487	Vas-Cath Permanent Single Lumen Hemodialysis Cath	Vas-Cath of Canada, Ltd.	LFJ	Class II	1987-06-12