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 2026-10-15, 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 3221 of 3528

510(k) clearances, page 3221 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821229	Cefoperazone 75Mcg. Antimicrobial Disk	General Diagnostics	JTN	Class II	1982-06-22
K821134	Dc Pack Tm	Seamless Hospital Products Co.	HFC	Class II	1982-06-22
K821092	Gammadab[125]ege Radioimmunoassay It	Clinical Assays, Inc.	DGC	Class II	1982-06-22
K821060	Fluoro-Cep	Zeus Scientific LLC			1982-06-22
K821017	Various Sterile Biopsy Aspiration Need	Medsurg Industries, Inc.	GAA	Class I	1982-06-22
K821002	Inverchair	Inverchair Marketing, Inc.	ITH	Class II	1982-06-22
K820939	C-101-P	Coratomic, Inc.	DXY	Class III	1982-06-22
K820641	Accurette	Axcan Scientific Corp.	HFF	Class II	1982-06-22
K821666	Sterile Surgical Drapes	Phoenix Glove Co.	FJZ	Class II	1982-06-21
K821618	Disposable Needle Holders	Medcare Products	FZX	Class I	1982-06-21
K821617	Disposable Hemostats	Medcare Products	HRQ	Class I	1982-06-21
K821563	Argyle Vac-U-Care 100Cc Suction Reserv	Sherwood Medical Co.	GCY	Class I	1982-06-21
K821522	Cervitrac Traction Frame & Cord	George W. Cottrell	HST	Class I	1982-06-21
K821403	Light Weight Aluminum Crutches	Manuco Manufacturing Co., Inc.	IPR	Class I	1982-06-21
K821313	Surgical Utility Drape	Megaplast, Inc.	FJZ	Class II	1982-06-21
K827525	Automatic Exposure Control Type A3300	Advanced Instrument Development, Inc.			1982-06-18
K821506	Medicotest ECG Electrodes	Medicotest, Inc.	DRX	Class II	1982-06-17
K821480	Right Atrial Catheters Parenteral Nutrit	The Healthcare Group Laboratories, Inc.	DQY	Class II	1982-06-17
K821456	Endotracheal Tube	Life-Line Products, Inc.	BTR	Class II	1982-06-17
K821442	William Harvey Flex. Venous Reservoir	C.R. Bard Inc	DTN	Class II	1982-06-17
K821401	Mallinckrodt Diag. Media Warmer	Forma Scientific, Inc.	DXT	Class II	1982-06-17
K821384	Exercise ECG Electrodes, Reusable	Respironics, Inc.	DRG	Class II	1982-06-17
K821223	Cr-9	Life Science Instrumentation, Inc.	DRT	Class II	1982-06-17
K820679	Pediatric Arterial Blood Filter #Af-540	Bentley Laboratories, Inc.	DTM	Class II	1982-06-17
K820343	Arterial Blood Filter Model #Af-1040	Bentley Laboratories, Inc.	DTM	Class II	1982-06-17
K812262	Medtronic a-V Pacing System Analyzer	Medtronic, Inc.	DTC	Class II	1982-06-17
K821700	Latex Penrose Drain Tubing	Abco Dealers, Inc.	GAX	Class I	1982-06-16
K821616	Cerviscope Optical System	Fotomedics, Inc.	HEX	Class II	1982-06-16
K821577	Deseret Angio Guide	Warner-Lambert Co.	FOZ	Class II	1982-06-16
K821523	Omni TENS	Omni Intl., Inc.	GZJ	Class II	1982-06-16
K821501	Sterile Tracheostomy Care Kit	Pro-Pak	KDD	Class I	1982-06-16
K821405	Magun Base i.v. Pole	Manuco Manufacturing Co., Inc.	FOX	Class I	1982-06-16
K821261	Puig Massana-Shiley Annuloplasty Ring	Shiley, Inc.	KRH	Class II	1982-06-16
K820941	Therma-Scan	T. G. & E. Medical			1982-06-16
K820459	Viragard/virashield	Tri-Med, Inc.	DRS	Class II	1982-06-16
K821653	Protriptyline Tri-Cy Test Set	Wien Laboratories, Inc.	LFG	Class II	1982-06-14
K821652	Doxepin Tri-Cy Test Set	Wien Laboratories, Inc.	LFG	Class II	1982-06-14
K821629	Fixident	Moyco Industries, Inc.	JET	Class I	1982-06-14
K821625	Endodontic Paperpoints	Roeko	EKN	Class I	1982-06-14
K821623	Nova IV Fluids Pack & External Standards	Shaban Mfg. Co.	JIX	Class II	1982-06-14
K821620	(125I) Htsh Radioimmunoassay Kit	Yang Laboratories, Inc.	JLW	Class II	1982-06-14
K821590	Pors-on	J. Aderer, Inc.	EJS	Class II	1982-06-14
K821584	Epistaxis Catheter/kit	Bivona Medical Technologies	EMX	Class I	1982-06-14
K821581	Den Temp	Majestic Drug Co., Inc.	EMB	Class I	1982-06-14
K821572	Duallor 'R'	J. Aderer, Inc.	EJS	Class II	1982-06-14
K821550	Model Ah Behing-the-Ear-Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1982-06-14
K821536	Dowflow Alt-UV Determination	The Dow Chemical Co.	CKA	Class I	1982-06-14
K821481	Nasal-Throat Spray Irrigation Instrum.	Ethicare Products	ETP	Class I	1982-06-14
K821444	Colored Wedge Used to Separate Teeth	Moyco Industries, Inc.	DZN	Class I	1982-06-14
K821440	V Lance	Sharpoint, Inc.	HNN	Class I	1982-06-14