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 3484 of 3526

510(k) clearances, page 3484 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770873	Circumcision Kit	American Hospital Supply	FHG	Class II	1977-07-11
K770831	Statzyme Uric Acid Reagent	Worthington Biochemical Corp.	CDO	Class I	1977-07-11
K770830	Platelet Agitator	Helmer Labs, Inc.	GLE	Class I	1977-07-11
K770825	Spectrophotometers,34,35,36,3600	Beckman Instruments, Inc.			1977-07-11
K770822	A-Gent Albumin	Abbott Medical	CIX	Class II	1977-07-11
K770820	Ultrachem Inorganic Phosphorus	Harleco	CEO	Class I	1977-07-11
K770819	Ultrachem Creatinine	Harleco	CGX	Class II	1977-07-11
K770818	Ultrazyme Plus, Ldh	Harleco	CFJ	Class II	1977-07-11
K770817	Ultrachem Calcium	Harleco	CJY	Class II	1977-07-11
K770816	Ultrachem Albumin	Harleco	CIX	Class II	1977-07-11
K770815	Ultrazyme Plus Gt	Harleco			1977-07-11
K770797	Tray, Catheterization W/foley, Sterile	Lukens Corp.	FRG	Class II	1977-07-11
K770795	Shave Prep Set	Lukens Corp.	JJX	Class I	1977-07-11
K770780	Reagents	Chemetrics Corp.	CHH	Class I	1977-07-11
K770774	Lytetek System	Boehringer Mannheim Corp.	JGT	Class II	1977-07-11
K770773	Pipette, Diluting, Model Adp-30Sd	G.D. Searle and Co.	JQW	Class I	1977-07-11
K770772	Pipette, Dispensing, Model Adp-30Sd	G.D. Searle and Co.	JQW	Class I	1977-07-11
K770730	Pump, Infusion, Dynatech/handley	Dynatech Medical Products	FRN	Class II	1977-07-11
K770724	Traction Devices, Intermittent, Tx	Chattanooga Pharmacal Co.	IRS	Class I	1977-07-11
K770723	Table, Treatment, Therapy, Physical	Chattanooga Pharmacal Co.	INT	Class I	1977-07-11
K770722	Thrombo Screen Quantitative Heparin Assa	Bay Area Hema. Onco. Clinic. & Res. L	JBR	Class II	1977-07-11
K770652	Fluorescence Illuminator Accessory	Bausch & Lomb Incorporated	IBK	Class I	1977-07-06
K770594	Laboratory Expendable Products	Abco Dealers, Inc.	JRC	Class I	1977-07-06
K771134	Anesthesia Breathing Circuit	Air Products & Chemicals, Inc.	CAI	Class I	1977-07-05
K771105	Nebulizer, Molel 503, Part #17068	Hospal Medical Corp.	CAF	Class II	1977-07-05
K771061	Oduflex Aerosol Set	BD Becton Dickinson Vacutainer Systems Preanalytic	CAF	Class II	1977-07-05
K771057	Anesthesia Machine	Foregger	BSZ	Class II	1977-07-05
K771035	Culture Test for Neisseria Gonorrhoeae	Miles Laboratories, Inc.	JTY	Class II	1977-07-05
K771028	Analyzer, Oxygen, Model Om-92	Cavitron Corp.	CCL	Class II	1977-07-05
K771027	Electrocardiographic Patient Cables	Tronomed, Inc.	DSA	Class II	1977-07-05
K770984	Ta-2 Temperature Alarm	Mistogen Equipment Co.	BZE	Class II	1977-07-05
K770946	Record, Model 702, I.l.	Instrumentation Laboratory Co.	DSF	Class I	1977-07-05
K770907	Spirometeo Exhaust	Timeter Instrument Corp.	BZK	Class II	1977-07-05
K770803	Hemotology Produ&ts (5 in All)	Hycel, Inc.	GKK	Class II	1977-07-05
K770792	Tube, Stain, Reticulocyte, Larc	Corning Medical & Scientific	KFC	Class I	1977-07-05
K770767	In Vitro Diag. for Uric Acid	Smithkline Diagnostics, Inc.	CDO	Class I	1977-07-05
K770750	Reagent Kit, Enzymatic Amylase	Beckman Instruments, Inc.	JFJ	Class II	1977-07-05
K770664	Nebulizer	J & S Industries, Inc.	CAF	Class II	1977-07-05
K771106	Forceps, Ob, Non-Compressive	Zeppelin Medizinlechnik GmbH	HDA	Class II	1977-07-01
K771096	Telhtherapy Simulator Aecl-Cp, G-3200	Atomic Energy of Canada	JAA	Class II	1977-07-01
K771058	Eptone Back-Up Broth, Vacutainer	BD Becton Dickinson Vacutainer Systems Preanalytic	JTW	Class I	1977-07-01
K771013	Mosquito	Emde Corp.	CBT	Class I	1977-07-01
K770954	Univue I	Union Carbide Corp.	IYX	Class I	1977-07-01
K770694	Cpk Ultrazyme Plus	Harleco Diagnostics	CGS	Class II	1977-07-01
K770680	Hematrak	Geometric Data, Div. Smithkline Corp.	GKZ	Class II	1977-07-01
K770438	Cart, Procedures	I E Industries	HDD	Class II	1977-07-01
K771056	Blood Collection Tube, Green	Sherwood Medical Industries	GIM	Class II	1977-06-29
K771055	Blood Collection Tube, Red	Sherwood Medical Industries	GIM	Class II	1977-06-29
K771054	Blood Collection Tube, Blue	Sherwood Medical Industries	GIM	Class II	1977-06-29
K771053	Blood Collection Tube, Gray	Sherwood Medical Industries	GIM	Class II	1977-06-29