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 3515 of 3526

510(k) clearances, page 3515 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760722	Birt-a-Chuck Disposable Electr. Handle	Birtcher Corp.	GEI	Class II	1976-11-01
K760686	Cryolyzer Alpha (Cryosurg.equip.)	Cryo-Labs, Inc.	GEH	Class II	1976-11-01
K760601	Argyle Suction Control Kit	Sherwood Medical Co.	GCY	Class I	1976-11-01
K760553	Printer	Turner Assoc.	JJQ	Class I	1976-11-01
K760546	Reagent Kit, Enzymatic CO2	Beckman Instruments, Inc.	KHS	Class II	1976-11-01
K760543	Bromcresol Green	Fisher Scientific Company L.L.C.	CIX	Class II	1976-11-01
K760476	Reagent, Lactate Dehydrogenase	Simmler & Son, Inc.	CFJ	Class II	1976-11-01
K760470	Counter, Rack Gamma (#1270)	Lkb Instruments, Inc.	JJJ	Class I	1976-11-01
K760468	Test, Reformulated Hycel Hma Calcium	Hycel, Inc.	CIC	Class II	1976-11-01
K760430	Bun-Reative	Boehringer Mannheim Corp.	CDS	Class II	1976-11-01
K760397	Reagent, Amp Buffer Diagnostic	J.T. Baker Chemical Co.	CJE	Class II	1976-11-01
K760395	Photometer, Serometer (Model 380)	Mallinckrodt Critical Care	JJQ	Class I	1976-11-01
K760394	Reagent, Chloridometer Acid	Bulcher Instruments	JFS	Class II	1976-11-01
K760373	Radioassay Kit, Im.72 Fsh	Amersham Corp.	CGJ	Class I	1976-11-01
K760366	Reagent, Y-Gt Max-Pack	Calbiochem	JPZ	Class I	1976-11-01
K760859	Tracor Model Ra 208 Compliance Audiom	Tracor Instruments, Inc.	EWO	Class II	1976-10-29
K760816	Pneumotachography System	Aftercal, Inc.	GWB	Class I	1976-10-29
K760802	T-3 Uptake Kit	Siemens Healthcare Diagnostics Inc.	KHQ	Class II	1976-10-29
K760790	Micro-Id	General Diagnostics	JSS	Class I	1976-10-29
K760764	Yeast Assimilation Agar	Bioquest	JSG	Class I	1976-10-29
K760719	Uniform Drop Size Pasteur Type Pipets	Dade, Baxter Travenol Diagnostics, Inc.	GJG	Class I	1976-10-29
K760672	Clinical Spectrophotometer	The Dow Chemical Co.	JJQ	Class I	1976-10-29
K760591	Sigma Procedure No. 745 - Ep.reagent Sy	Sigma Chemical Co.	JHX	Class II	1976-10-29
K760499	Reagent, Partial Thromboplastin	Hyland Therapeutic Div., Travenol Laboratories			1976-10-29
K760480	Reagent, Total Protein Determination	Simmler & Son, Inc.	CEK	Class II	1976-10-29
K760479	Reagent, Total Bilirubin Determination	Simmler & Son, Inc.	CIG	Class II	1976-10-29
K760478	Reagent, Bun (Urea Nitrogen) Determ.	Simmler & Son, Inc.	CDW	Class II	1976-10-29
K760477	Reagents-4 for Uric Acid Determination	Simmler & Son, Inc.	CDH	Class I	1976-10-29
K760475	Reagent, Calcium Determination	Simmler & Son, Inc.	CIC	Class II	1976-10-29
K760474	Reagent, Alkaline Phosphatase Determ.	Simmler & Son, Inc.	CJE	Class II	1976-10-29
K760473	Reagent, Albumin Determination	Simmler & Son, Inc.	CIX	Class II	1976-10-29
K760472	Instrumented System for Urinalysis	Miles Laboratories, Inc.	KQO	Class I	1976-10-29
K760467	Rotator, Fixed Speed	Lederle Laboratories	JQC	Class I	1976-10-29
K760449	Lipid Control	Sigma Chemical Co.	JJX	Class I	1976-10-29
K760411	Nad (Spoonpak Container)	J.T. Baker Chemical Co.	CFJ	Class II	1976-10-29
K760410	Amp Buffer	J.T. Baker Chemical Co.	CFJ	Class II	1976-10-29
K760407	Sulfanilic Acid	J.T. Baker Chemical Co.	CIG	Class II	1976-10-29
K760406	Caffeine Diluent	J.T. Baker Chemical Co.	CIG	Class II	1976-10-29
K760398	Reagent, Magnesium Chloride	J.T. Baker Chemical Co.	CJE	Class II	1976-10-29
K760353	Cryolyzer Alpha	Pilling Co.	GEH	Class II	1976-10-29
K760350	Monitor, Citadel Intravascular Po2	Sherwood Medical Industries	CCE	Class II	1976-10-29
K760506	Hemaflour Zp	Buchler Instruments, Inc.	KHO	Class I	1976-10-28
K760339	Monitor, Respiratory (CPAP)	Sherwood Medical Industries	BZQ	Class II	1976-10-28
K760845	Solo-Sphere Heater	Respiratory Therapy	CAF	Class II	1976-10-27
K760819	Conductive Anesthesia Breathing Circuit	Omnicon Medical Corp.	CAI	Class I	1976-10-27
K760725	Coil Machine Adapter	Gambro, Inc.	FLC	Class II	1976-10-27
K760374	Dialyzer (Model 1850)	Erika, Inc.	FHS	Class II	1976-10-27
K760357	Skin Clip System, Disposable (Avlox Ici)	V. Mueller O.V. Baxter Healthcare Corp.	FZG	Class II	1976-10-27
K760348	Reagent System, Sigma Procedure No. 270	Sigma Chemical Co.	CCZ	Class I	1976-10-27
K760346	Assay for Gamma Glutamyltransferase	Princeton Biomedix	JPZ	Class I	1976-10-27