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 2026-10-08, 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 3396 of 3526

510(k) clearances, page 3396 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791101	Disposable Perforators, Jacobs, Hudson	Cerenovus, Inc.	HBF	Class II	1979-08-28
K790893	Stat	Varian Assoc., Inc.	HKP	Class II	1979-08-28
K790637	Computerized Electro-Oculograph	Potomac Medical System	HLX	Class II	1979-08-28
K782049	Bioassay System, Ms-2 Serum	Abbott Medical	DJB	Class II	1979-08-28
K791520	Emb Agar (Eosin Methylene Blue Agar)	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-08-22
K791519	Levine Emb Agar	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-08-22
K791518	Biggy Agar	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-08-22
K791517	Columbia Blood Agar	Isle Media and Sterile Products, Inc.	JSG	Class I	1979-08-22
K791516	Tryptic Soy Agar	Isle Media and Sterile Products, Inc.	JSG	Class I	1979-08-22
K791515	Transport Medium Stuart W/ Charcoal	Isle Media and Sterile Products, Inc.	JSM	Class I	1979-08-22
K791514	Transport Medium Stuart	Isle Media and Sterile Products, Inc.	JSM	Class I	1979-08-22
K791485	Mueller Hinton Agars	Isle Media and Sterile Products, Inc.	JTZ	Class II	1979-08-22
K791484	Selenite Broth	Isle Media and Sterile Products, Inc.	JSD	Class I	1979-08-22
K791483	Thayer-Martin Medium	Isle Media and Sterile Products, Inc.	JTY	Class II	1979-08-22
K791482	Macconkey Media	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-08-22
K791481	Lauryl Tryptose Broth	Isle Media and Sterile Products, Inc.	JSD	Class I	1979-08-22
K791480	Ss Agar (Salmonella Shigella Agar)	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-08-22
K791473	Triple Sugar Iron Agar (Tsi Agar)	Isle Media and Sterile Products, Inc.	JSE	Class I	1979-08-22
K791472	Phenylethanol Agag (Pea)	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-08-22
K791471	Selenite Cystine Broth	Isle Media and Sterile Products, Inc.	JSD	Class I	1979-08-22
K791470	Modified Thayer-Martin Medium	Isle Media and Sterile Products, Inc.	JTY	Class II	1979-08-22
K791468	Resusci-Bag-Valve	Concept, Inc.	BTM	Class II	1979-08-22
K791428	Glucohemoglobin Control	BD Becton Dickinson Vacutainer Systems Preanalytic	LCP	Class II	1979-08-22
K791407	Womed Nicro-Craft Power System	Xomed, Inc.	ERL	Class II	1979-08-22
K791398	Culture Media for Insolation Neisseria	Isle Media and Sterile Products, Inc.	JTY	Class II	1979-08-22
K791327	Argyle Taussig Culture Catheter	Sherwood Medical Co.	KTR	Class II	1979-08-22
K791277	Model 6500 Extraction Irrigation Sys	Cavitron Corp.	HDQ	Class I	1979-08-22
K791222	Api 20E Reagent Qc	Analytical Products, Inc.	JSE	Class I	1979-08-22
K791187	Model 810 Veri/tgs	Verite	GZJ	Class II	1979-08-22
K791074	Model Mhs-20, Atomic Absorption Access	Revvity Health Sciences, Inc.	JXR	Class I	1979-08-22
K790708	Antiserum to Human Ig G Fc Fragments	Kent Laboratories, Inc.	DAS	Class I	1979-08-22
K791503	Vitalograph Function Analyzer	Vitalograph, Inc.	BZC	Class II	1979-08-16
K791466	Ace External Bone Clamp Part #S11	Ace Orthopedic Manufacturing Co.	JEC	Class II	1979-08-16
K791435	Ames Tda/tobramycin	Miles Laboratories, Inc.	KLB	Class II	1979-08-16
K791412	Disposable Instrument Tray Pad	Anago, Inc.	KCT	Class II	1979-08-16
K791400	Gastric Lavage Kit-Disposable	Acumed Instruments Corp.	GBQ	Class I	1979-08-16
K791396	Medi-Trak Portable Traction Device	Medicorp, Inc.	HST	Class I	1979-08-16
K791395	Anti-Histoplasma Serum #Cf10025x	IMMY, Inc.	GMK	Class II	1979-08-16
K791394	Histoplasma Mycelial #Cf10020x	IMMY, Inc.	GMJ	Class II	1979-08-16
K791393	Histoplasma Yeast Anti #Cf10021x	IMMY, Inc.	GMJ	Class II	1979-08-16
K791392	Anti-Histoplasma Serum #Cf10026x	IMMY, Inc.	GMK	Class II	1979-08-16
K791390	Anti-Blastomyces Serum #Cf10027x	IMMY, Inc.	GMK	Class II	1979-08-16
K791389	Coccidioides Antigen #Cf10023x	IMMY, Inc.	GMI	Class II	1979-08-16
K791388	Anti-Coccidioides Serum #Cf10028x	IMMY, Inc.	GMH	Class II	1979-08-16
K791387	Aspergillus Mycelial Antigen #Cf10024x	IMMY, Inc.	JWT	Class I	1979-08-16
K791386	Anti-Aspergillus (Mycelial) Contr Serum	IMMY, Inc.	KFG	Class I	1979-08-16
K791385	Negative Control Serum for Cf Ro Id	IMMY, Inc.	GSN	Class II	1979-08-16
K791384	Fungal Immunodiffusion Kit #Id1001	IMMY, Inc.	GMJ	Class II	1979-08-16
K791383	Candida Immunodiffusion Kit #Ca1001	IMMY, Inc.	GMI	Class II	1979-08-16
K791382	Cryptococcal Antigen Latex Agglutination	IMMY, Inc.	GMD	Class II	1979-08-16