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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3023 of 3529

510(k) clearances, page 3023 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844869	Fiberlase 100 Medical Laser System	Laser Media	LLO	Class II	1985-01-14
K844865	Securline Surgical Skin Marker 1000	Precision Dynamics Corporation	FZZ	Class I	1985-01-14
K844802	Surgical Drapes	Procter & Gamble Mfg. Co.	KKX	Class II	1985-01-14
K844746	Tracheal Tube W/airway Intubator	Sheridan Catheter Corp.	BTR	Class II	1985-01-14
K844632	Infant Limb Electrode	Sentry Medical Products, Inc.	DRX	Class II	1985-01-14
K844556	Khm 2000 Drip Watcher	The Timeter Group	FLN	Class II	1985-01-14
K844447	M/d4 W/charger (Cardiopac 3M11)	Datascope Corp.	LDD	Class II	1985-01-14
K844421	Foregger Dome Valves	Medtronic, Inc.	BSZ	Class II	1985-01-14
K844367	Cardiotomy Reservoir W/filter Bcr-2500	American Bentley	DTN	Class II	1985-01-14
K844366	Cardiotomy Reservoir Bcr-2000	American Bentley	DTN	Class II	1985-01-14
K844229	Venous Reservoir Vrs-Xxx Series; Holder Vrs-Hxx	Gish Biomedical, Inc.	DTN	Class II	1985-01-14
K844106	Syringe W/needle Combin & Syringe Only	Abco Dealers, Inc.	FMF	Class II	1985-01-14
K844089	Castle 7515 Utensil/glassware Washer	Castle Co.	LDS	Class II	1985-01-14
K843640	Xenon Xe 127/Xe 133 Gas Dispenser	Mallinckrodt Critical Care	IYT	Class II	1985-01-14
K843639	Add-a-Vial Solution Transfer Device	American Mcgaw	LHI	Class II	1985-01-14
K843290	Numed Balloon Pacing Catheter	Numed Inc	LDF	Class II	1985-01-14
K843232	Shiley Hardshell Venous Reservoir W/int	Shiley, Inc.	DTN	Class II	1985-01-14
K842888	Dual Channel TENS, Pulsar Remote Contrl	Cryomedics LLC	GZJ	Class II	1985-01-14
K842371	Lee Syringe	Peter F. Lee, Inc.			1985-01-14
K841880	Erythrocath Umbilical Catheter	Cardio Search, Inc.	FOZ	Class II	1985-01-14
K841401	Sat-1 Oximeter/cardiac Output Computer	American Edwards Laboratories	DXG	Class II	1985-01-14
K844959	Medtronic 6304, 6305,6306,6506 & 6506W. Temp.pacin	Medtronic, Inc.	DTB	Class III	1985-01-10
K844705	Shoe Covers	Medicon Co., Ltd.	FXP	Class I	1985-01-10
K844704	Caps (o.r. Nurse, Surgical)	Medicon Co., Ltd.	FYF	Class I	1985-01-10
K844703	Gowns, Surgical	Medicon Co., Ltd.	FYA	Class II	1985-01-10
K844613	General Purpose Instrument Trays Suture Removal Tr	Packaging Technologies, Inc.	FSM	Class I	1985-01-10
K844470	Fukuda Denshi Model Fcp-220	Brentwood Instruments, Inc.	DPS	Class II	1985-01-10
K844444	Esophageal Stethoscope	Medical Parameters, Inc.	BZW	Class I	1985-01-10
K844376	Model 78210A Telemetry Transmitter	Hewlett-Packard Co.	DRG	Class II	1985-01-10
K844342	Sure & Natural Maxishields W/superabsorbent	Personal Products Co.	HHD	Class I	1985-01-10
K844334	Vivalith II 301 Pulse Generator	Pacesetter Systems	DXY	Class III	1985-01-10
K844290	L100d Patient Circuit Dual Line	Life Products, Inc.	BZO	Class I	1985-01-10
K844253	Novametrix 811 Transco2m Portable Transcutaneous 2	Novametrix Medical Systems, Inc.	KLK	Class II	1985-01-10
K844213	Stimtech Sd Patient 6089 #78-8050	Cerenovus, Inc.	GZJ	Class II	1985-01-10
K844212	Stimtech Sd Clinician 6090 #78-8055	Cerenovus, Inc.	GZJ	Class II	1985-01-10
K843912	Intravascular Blood Gas System	Cardiovascular Devices, Inc.	CCE	Class II	1985-01-10
K843907	Porous Coated Titanium Knee Prosthes-	Johnson & Johnson Professionals, Inc.	JWH	Class II	1985-01-10
K843724	i.v. Start Kit & Obstetrical Kit	E.M. Adams Co., Inc.	KKX	Class II	1985-01-10
K843687	Rod for Rachis Surgery	Sofamor Co.	KWP	Class II	1985-01-10
K843624	Cofield Shoulder System	Richards Medical Co., Inc.	KWS	Class II	1985-01-10
K843245	Hearing Aid, Unitron Ue12-Pp	Unitron Industries, Inc.	ESD	Class I	1985-01-10
K842784	Ceregrotrac	Advanced Instruments, LLC	GWQ	Class II	1985-01-10
K842193	Multilith Pulse Generators, 1141 & 2141	Ela Medical, Inc.	DXY	Class III	1985-01-10
K823844	Horizon ECG System	Beckman Instruments, Inc.	DSI	Class II	1985-01-10
K844870	Suntan Connections Bahama Sun-Booth	Suntan Connection	FTC	Class II	1985-01-09
K844626	Mini Flow- Dental Floss	Mini Floss	JES	Class I	1985-01-09
K844619	Endoneedle	Endotherapeutics	FHO	Class II	1985-01-09
K844395	Renaissance	Williams Gold Refining Co., Inc.	EJT	Class II	1985-01-09
K844394	Renaissance Bonding Agent	Williams Gold Refining Co., Inc.	EJT	Class II	1985-01-09
K844340	Travenol Reconstitution Device W/admix Cap	Travenol Laboratories, S.A.	LHI	Class II	1985-01-09