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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3522 of 3526

510(k) clearances, page 3522 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760413	Tape, Lightcast II Wb	Solar Laboratories, Inc.	ITG	Class I	1976-08-23
K760405	Sealant, New Filled	L.D. Caulk Co.	EBC	Class II	1976-08-23
K760404	Bi-Centric System	KaVo Dental Technologies, LLC	KLC	Class I	1976-08-23
K760403	Temporary Atrial Electrode Kit	Usci, Div. C.R. Bard, Inc.	DRE	Class II	1976-08-23
K760402	Syringe Set, 3-Way Thermodilutin	Omp Laboratories, Inc.	DQO	Class II	1976-08-23
K760400	Bonding Agent, Vytol	L.D. Caulk Co.	KLE	Class II	1976-08-23
K760393	Bed Pan, Stackable (Autoclavable)	Bemis Health Care	FOB	Class I	1976-08-23
K760379	Dental Amalgam Alloy (Spherical II)	L.D. Caulk Co.	EJS	Class II	1976-08-23
K760378	Cement, Resin Dental (Auto-Tach)	L.D. Caulk Co.	DYH	Class II	1976-08-23
K760377	Filling, Resin Dental (Vytol)	L.D. Caulk Co.	EBF	Class II	1976-08-23
K760376	Cement, Resin Dental (Solo-Tach)	L.D. Caulk Co.	DYH	Class II	1976-08-23
K760370	Infusion Equipment, Intravenous	Medtronic, Inc.	FRN	Class II	1976-08-23
K760358	Electrode Series 1600	Andover Medical, Inc.	DRX	Class II	1976-08-23
K760351	Catheter, Argyle Thoracic	Sherwood Medical Industries	DWS	Class I	1976-08-23
K760332	Sigma Ammonia Reagent	Sigma Chemical Co.	JIF	Class I	1976-08-23
K760280	Electrode Series 1401	Andover Medical, Inc.	DRX	Class II	1976-08-23
K760265	Elctrocardiograph, Ek-6	Burdick Corp.	DPS	Class II	1976-08-23
K760259	Catheter 3-Way Silicone Foley	Travenol Laboratories, S.A.	KOD	Class II	1976-08-23
K760254	Tray, Foley Catheter	C.R. Bard Inc	GBM	Class II	1976-08-23
K760253	Tray, Universal Foly Wo/drainage Bag	C.R. Bard Inc	GBM	Class II	1976-08-23
K760244	Radioear, Personal	Radioear Corp.	ESD	Class I	1976-08-23
K760234	Oximeter, in Vivo Catheter	Oximetrix, Inc.	DQE	Class II	1976-08-23
K760217	Suction Instrument, Macbick Dis. Fraz.	C.R. Bard Inc	GCX	Class II	1976-08-23
K760216	Suction Instrument, Macbick Poole Tip	C.R. Bard Inc	GCX	Class II	1976-08-23
K760093	Catheter, Silicone Foley (Bardex)	C.R. Bard Inc	GBM	Class II	1976-08-23
K760005	Syringe, Disposable, Glass & Plastic	Stewart-Naumann Laboratories	FMF	Class II	1976-08-23
K760004	Syringe, Disposable, All Plastic	Stewart-Naumann Laboratories	FMF	Class II	1976-08-23
K760158	Needles and Sutures, Silk & Nylon	Alcon Laboratories	GAP	Class II	1976-08-19
K760372	Humidifier, Disposable	Hospitek	BTT	Class II	1976-08-13
K760371	Vent-O2-Cath	Dryden Corp.	BSY	Class I	1976-08-13
K760279	X-Ray Film, Convey or System	Mallinckrodt Group, Inc.	KPX	Class II	1976-08-13
K760369	Powderlite	The S. S. White Co.	EBF	Class II	1976-08-11
K760365	Blanket, Burn	Winn Hirsch & Assoc.	FPY	Class I	1976-08-11
K760354	Test, Slide for C-Reative Protein	Icl Scientific	DCK	Class II	1976-08-11
K760352	Circuit, Intensive Care Ventilator	Monaghan Medical Corp.	CAZ	Class II	1976-08-11
K760343	Tray, Curity Continuous Epidural	Kendall Research Center	CAZ	Class II	1976-08-11
K760342	Razor, Schick Disposable	Parke-Davis Co.	LDQ		1976-08-11
K760341	Humidifier, Electronic (Eh147)	Mistogen Equipment Co.	KFZ	Class I	1976-08-11
K760340	Respiratory Support System, Neonatal	Sherwood Medical Industries	BZQ	Class II	1976-08-11
K760338	Monitor, Resp. Oxygen (Top)	Sherwood Medical Industries	CCL	Class II	1976-08-11
K760337	Cannula, Argyle Nasal Oxygen	Sherwood Medical Industries	CAT	Class I	1976-08-11
K760335	Nebulizer, Micro (Addi-Mist)	Respiratory Care, Inc.	CAF	Class II	1976-08-11
K760334	Prostehsis, Total Knee Replacement	Depuy, Inc.	HRY	Class II	1976-08-11
K760331	Turbine, Air Driven Handpiece (2000)	Litton Dental Products	EFB	Class I	1976-08-11
K760328	Razor, Disposable	Devon Industries, Inc.	LDQ		1976-08-11
K760319	Kit, Catheter	Jelco Laboratories	FOZ	Class II	1976-08-11
K760315	Pad, Polyether Foam, Open Cell	Gaymar Industries, Inc.	FNJ	Class I	1976-08-11
K760308	i.v. Support, Tecnol Armboard	Tecnol New Jersey Wound Care, Inc.	FSE	Class I	1976-08-11
K760307	Bedpan, Single Patient Use, Tecnol	Tecnol New Jersey Wound Care, Inc.	FOB	Class I	1976-08-11
K760277	Underpad Code No. 8453	Johnson & Johnson Professionals, Inc.	EYQ	Class I	1976-08-11