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 3372 of 3526

510(k) clearances, page 3372 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792712	Para-Pak (C&s)	Meridian Diagnostics, Inc.	JSM	Class I	1980-01-17
K792711	Histoplasma Capsulatum, Antiserum	Meridian Diagnostics, Inc.	GMJ	Class II	1980-01-17
K792708	Histoplasma Capsulatum, Mycelial Phase	Meridian Diagnostics, Inc.	GMJ	Class II	1980-01-17
K792704	Histoplasma Capsulatum, Antigen Yeast	Meridian Diagnostics, Inc.	GMJ	Class II	1980-01-17
K792700	Aspergillus Sp, Complement Fixation	Meridian Diagnostics, Inc.	JWT	Class I	1980-01-17
K792698	Aspergillus Sp, Antiserum, Positive	Meridian Diagnostics, Inc.	KFG	Class I	1980-01-17
K792691	Cryptococcus Neoformans, Antigen,	Meridian Diagnostics, Inc.	JWK	Class II	1980-01-17
K792690	Coccidioides Immitis, Latex Aggluti	Meridian Diagnostics, Inc.	GMG	Class II	1980-01-17
K792689	Coccidioides Immitis, Antigen	Meridian Diagnostics, Inc.	GMI	Class II	1980-01-17
K792688	Coccidioides Immitis, Antiserum	Meridian Diagnostics, Inc.	GMH	Class II	1980-01-17
K792687	Aspergillus Sp., Antigen	Meridian Diagnostics, Inc.	JWI	Class II	1980-01-17
K792686	Aspergillus Sp, Antiserum Positive	Meridian Diagnostics, Inc.	KFG	Class I	1980-01-17
K792685	Blastomyces Dermatitidis, Antiserum	Meridian Diagnostics, Inc.	KFH	Class II	1980-01-17
K792684	Coccidioides Immitis, Antiserum,	Meridian Diagnostics, Inc.	GMH	Class II	1980-01-17
K792682	Coccidioides Immitis, Antigen	Meridian Diagnostics, Inc.	GMI	Class II	1980-01-17
K792681	Blastomyces Dermatitidis Pos/control	Meridian Diagnostics, Inc.	KFH	Class II	1980-01-17
K792680	Blastomyces Dermatitidis, Antigen	Meridian Diagnostics, Inc.	JWW	Class II	1980-01-17
K792679	Histoplasma Capsulatum, Antiserum	Meridian Diagnostics, Inc.	GMK	Class II	1980-01-17
K792671	Cobas-Bio Centrifugal Analyzer	Hoffmann-La Roche, Inc.	JJG	Class I	1980-01-17
K792662	Autopak-12 Uptake Test Delivery System	Micromedic Systems	KHQ	Class II	1980-01-17
K792658	Cobas-Blo Reagents (Lactate Dehydro	Hoffmann-La Roche, Inc.	CFJ	Class II	1980-01-17
K792587	Venoject Autosep	Kimble-Terumo, Inc.	JKA	Class II	1980-01-17
K792540	Sonacolor 6000	Carolina Medical Electronics	DXK	Class II	1980-01-17
K792439	Analyte Cortisol	Technicon Instruments Corp.	CGR	Class II	1980-01-17
K790555	Hemo-Wedge	Parker Laboratories, Inc.	DZN	Class I	1980-01-17
K792719	3 Way Urethral Irrigation Catheter	Vesta, Inc.	KOD	Class II	1980-01-16
K792667	Leukoclip Poros	Beiersdorf, Inc.	FPX	Class I	1980-01-16
K792666	Leukopor	Beiersdorf, Inc.	KGX	Class I	1980-01-16
K792657	Sensi-Slide	Hoffmann-La Roche, Inc.	JHJ	Class II	1980-01-16
K792652	Leeco P.a.p. Quant. Diagnostic Kit	Leeco Diagnostics, Inc.	JFH	Class II	1980-01-16
K792634	Conceptrol/thin Prophylactics	Ortho Pharmaceutical Corp.	HIS	Class II	1980-01-16
K792632	Sterilization Process/bulb Syringe	Procter & Gamble Mfg. Co.			1980-01-16
K792626	Sterilization Process/baby Blanket	Procter & Gamble Mfg. Co.	KME	Class I	1980-01-16
K792625	Sterilization Process/placenta Basin	Procter & Gamble Mfg. Co.	FNY	Class I	1980-01-16
K792607	T3 Uptake (T3u) Reagents	Dade, Baxter Travenol Diagnostics, Inc.	KHQ	Class II	1980-01-16
K792605	Chloride Reagent	Gilford Diagnostics	CHJ	Class II	1980-01-16
K792599	Tipsep-T4(ria) T4 Radioimmunoassay	Nuclear Diagnostics, Inc.	CDX	Class II	1980-01-16
K792583	Gamma Arachis Hypogea Lectin	Gamma Biologicals, Inc.	KSI	Class II	1980-01-16
K792582	Poly-Lec System	Gamma Biologicals, Inc.	KSI	Class II	1980-01-16
K792581	General Electric Panelipse Ld	General Electric Co.	EHD	Class II	1980-01-16
K792562	Immunostat Tsh Test	Meloy Laboratories, Inc.	JLW	Class II	1980-01-16
K792557	Spectrophatometer Models 2280 & 2380Aa	Revvity Health Sciences, Inc.	JXR	Class I	1980-01-16
K792556	Naso Stent	Tripedsil, Inc.			1980-01-16
K792555	Elvi Non-Esterified Fatty Acids	Volu Sol Medical Industries	JLH	Class I	1980-01-16
K792554	Elvi Mucaproteins	Volu Sol Medical Industries	JQN	Class I	1980-01-16
K792550	Ponceau S Stain Set	Electrophoresis Corp. of America	KQC	Class I	1980-01-16
K792539	Triiodothyronine Ria System	Radioimmunoassay, Inc.	CDP	Class II	1980-01-16
K792534	Neochrome II Glucose, #4044	American Monitor Corp.	CGA	Class II	1980-01-16
K792524	Ck-Mb (Creatine Kinase-Mb) Ria Control	Mallinckrodt Critical Care	JJX	Class I	1980-01-16
K792504	Ria-Quant Ck-Mb Test Kit	Mallinckrodt Critical Care	JHX	Class II	1980-01-16