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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3330 of 3528

510(k) clearances, page 3330 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802418	Fetal Bovine Serum	S&S Biologicals	KIS	Class I	1980-10-31
K802415	Bhi Agar/bhi Broth Biphasic Blood Clt.bt	Remel Co.	JSG	Class I	1980-10-31
K802410	Microthin-Pi Bipolar Pulse Generator	Cardiac Pacemakers, Inc.	DXY	Class III	1980-10-31
K802409	Microthin-Di Bipolar Pulse Generator	Cardiac Pacemakers, Inc.	DXY	Class III	1980-10-31
K802407	Pacemaker Lead Adaptor Model 431	Pacesetter Systems	DTD	Class II	1980-10-31
K802398	Electroly Te Chemistry Analyzer	Instrumentation Laboratory Co.	JJF	Class I	1980-10-31
K802380	Aria II 125 I Cortisol	BD Becton Dickinson Vacutainer Systems Preanalytic	CGR	Class II	1980-10-31
K802379	Hem-O-Scan Oxygen Equil. Curve Analyzer	American Instrument Co.	LCH	Class I	1980-10-31
K802377	Moti Protective X-Ray Mask	Moti Enterprises, Inc.	KPY	Class I	1980-10-31
K802360	Uterine Vacum Aspirating Currette	American Hospital Supply	HHI	Class II	1980-10-31
K802359	Disp. Fenestrated Surg. Drape Sheets	American Convertors Div., American Pharmaseal	KKX	Class II	1980-10-31
K802337	Phadebact Pneumococcus Test	Pharmacia, Inc.	GWC	Class I	1980-10-31
K802320	Coulter Dacos Serum Chem. Analyzer	Coulter Electronics, Inc.	JJE	Class I	1980-10-31
K802317	Comfort Cushion Dry Burn Pads, Sterile	American Convertors Div., American Pharmaseal	KKX	Class II	1980-10-31
K802303	Viral Transport Med. (46-995-04)	Flow Laboratories, Inc.	JSM	Class I	1980-10-31
K802293	Polyflex Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1980-10-31
K802291	Fluorescent Sun Lamp Fixture	Strato-Ray Co.	HJE	Class II	1980-10-31
K802264	Wash Solution Kit, #88102	Hi Chem, Inc.	JJF	Class I	1980-10-31
K802263	Minivisor Terminal	bioMerieux, Inc.	IYO	Class II	1980-10-31
K802257	Goat Anti-Human Igg Gamma Chain Specific	Protos Laboratories	DEW	Class II	1980-10-31
K802196	Goat Anti-Human Complement C4	Protos Laboratories	DBI	Class II	1980-10-31
K802182	Wisconsin Heart Rate Monitor	Lunar Radiation Corp.	DRT	Class II	1980-10-31
K802177	Goat Anti-Human Igm	Protos Laboratories	DFT	Class II	1980-10-31
K802171	Kodak Ortho L Film	Eastman Kodak Company	IWZ	Class I	1980-10-31
K802139	Spatula, Cervical Cytological Cytology	Dyn-A-Med Products	HHT	Class II	1980-10-31
K802138	Cheek Tool Set	Cerenovus, Inc.	GWM	Class II	1980-10-31
K802137	Cheek Epidural Screw	Cerenovus, Inc.	GWM	Class II	1980-10-31
K802131	Cybrex Lidocaine	Abbott Medical	KLR	Class II	1980-10-31
K802011	Infussion Alarm System I.a.s. Cat.#1118	Pollak (Intl.).ltd	FLN	Class II	1980-10-31
K802009	Flowclamp Cat.#1011 & 1012	Pollak (Intl.).ltd	FKK	Class I	1980-10-31
K801921	Gcs-79	Gilmore Liquid Air Co.	GEH	Class II	1980-10-31
K801848	Ica1 Ionized Calcium Analyzer	The London Co.	JFP	Class II	1980-10-31
K801837	Plastic Strip Bandages	Martin'S Maine Exchange	FPX	Class I	1980-10-31
K801791	Fertility Awareness Method Kit	Telesis Corp.	FLK	Class II	1980-10-31
K801729	Androstenedione Radioimmunoassay Kit	Diagnostics Biochem Canada, Inc.	CIZ	Class I	1980-10-31
K801574	Depalma Elbow	Zimmer GmbH	JDB	Class II	1980-10-31
K801559	Hollo Fiber Dialyzer	Renal Devices, Inc.	FJI	Class II	1980-10-31
K801553	Thermocomp	Hospital Financial Corp.	IYM	Class III	1980-10-31
K801416	Pacepath Model 810	Pacesetter Systems	DTB	Class III	1980-10-31
K801233	Celltrifuge II	Travenol Laboratories, S.A.	GKT	Class II	1980-10-31
K801219	Plasmapooler	North American Biologicals, Inc.	KSR	Class II	1980-10-31
K801082	Gambro Hemofreeze-Bag	Gambro, Inc.	KSR	Class II	1980-10-31
K801055	Compupace, 524-01 Pacer System Computer	Intermedics, Inc.	DTE	Class II	1980-10-31
K802689	L-15T Endocardial Pacing Electrode	Coratomic, Inc.			1980-10-28
K802691	Occupak Cat.#200-0538	Occumedics, Inc.			1980-10-27
K802671	Empty Transfer Bags	Delmed, Inc.			1980-10-27
K802510	Dahlberg Hearing Aid Model Ai	Dahlberg Electronics, Inc.	ESD	Class I	1980-10-23
K802459	Siemens-Elema Ab CO2 Monitor 130	Siemens Elema AB	CCK	Class II	1980-10-23
K802444	Papillotome Product	Mill-Rose Laboratory	KNS	Class II	1980-10-23
K802443	E.r.c.p. Cannula Product	Mill-Rose Laboratory	ODD	Class II	1980-10-23