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 3469 of 3526

510(k) clearances, page 3469 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771987	Micropulse 26U Pulse Generator	Edwards Pacemaker Systems	DXY	Class III	1977-11-02
K771985	Filter Sampler Blood Serum Filter	Clasrock	GIM	Class II	1977-11-02
K771982	888 Arterial/venous Catheter Introducer	Usci, Div. C.R. Bard, Inc.	DYB	Class II	1977-11-02
K771980	Fever Tester	American Thermometer Company, Inc.	KPD	Class II	1977-11-02
K771970	Whirlpool Bath Model 50	Dazey Products Co.	ILJ	Class II	1977-11-02
K771969	Turbo-Jet Model 76	Dazey Products Co.	ILJ	Class II	1977-11-02
K771966	Vibro Bath Model Fs-1	Dazey Products Co.	ILJ	Class II	1977-11-02
K771941	Quantrols Im	Organon LLC			1977-11-02
K771940	Quantrols RF	Organon LLC	DHR	Class II	1977-11-02
K771938	Alginate Impression Material	The S. S. White Co.	ELW	Class II	1977-11-02
K771925	Krystalonr Liq. Mounting Med.&coverslip	Harleco	KES	Class I	1977-11-02
K771922	Miniclinic Tm	Instromedix, Inc.	DTC	Class II	1977-11-02
K771893	Disposable Elhctrode	Chase Medical Services	GYB	Class II	1977-11-02
K771891	Catheter, Umbilical, Vicra	Travenol Laboratories, S.A.	FOS	Class II	1977-11-02
K771885	Imported Pain Control Device	Empi	GZJ	Class II	1977-11-02
K771869	Diag. Ultrasound B-Scanner	Accusonics, Inc.	HGL	Class II	1977-11-02
K771852	Nimetic Polishing Paste	Espe GmbH (US)	EJR	Class I	1977-11-02
K771847	Temp-Tester	Jablecki, Charles, Dr.	GXB	Class I	1977-11-02
K771839	Sodium	Gamma Enterprises, Inc.	JGS	Class II	1977-11-02
K771837	Potassium	Gamma Enterprises, Inc.	CEM	Class II	1977-11-02
K771835	Inorganic Phosphorus	Gamma Enterprises, Inc.	CEO	Class I	1977-11-02
K771829	Alkaline Phosphatase	Gamma Enterprises, Inc.	CJE	Class II	1977-11-02
K771793	Dhea Test Set	Wien Laboratories, Inc.	CIY	Class I	1977-11-02
K772013	Percupass Tunneling Tool Model 3452	Medtronic, Inc.	HAO	Class I	1977-10-28
K771986	Catheter, Mediastinal&pericardial	The Minnesota Back Brace Co.	FHF	Class II	1977-10-28
K771975	Arterial Blood Sampling Tray	Respiratory Care, Inc.	CBT	Class I	1977-10-28
K771968	Whirlpool Bath Model 2273	Dazey Products Co.	ILJ	Class II	1977-10-28
K771967	Whirlpool Bath Model 2270	Dazey Products Co.	ILJ	Class II	1977-10-28
K771965	Whirlpool Bath Model 2274	Dozey Products Co.	ILJ	Class II	1977-10-28
K771957	Rubella Hemagglutination Reagent Kit	Flow Laboratories, Inc.	GOK	Class II	1977-10-28
K771956	Human O Buffer	Flow Laboratories, Inc.	GOK	Class II	1977-10-28
K771876	Argyle Peocussor System	Sherwood Medical Industries	BYI	Class II	1977-10-28
K771848	Phosphorus Test Kit	Mallinckrodt Critical Care	CEO	Class I	1977-10-28
K771798	Aca Bilirubin Calibrator	E.I. Dupont de Nemours & Co., Inc.	JJX	Class I	1977-10-28
K771686	Ureaplasma Differential Basal Agar Med.	Gibco Laboratories Life Technologies, Inc.	JSH	Class I	1977-10-28
K771124	Instrument Tray Pad	Devon Industries, Inc.	KCT	Class II	1977-10-28
K771123	Surgical Instrument Protector	Devon Industries, Inc.	KCT	Class II	1977-10-28
K771942	Tilt 10, Catalog #S-2600	Affiliated Hospital Products, Inc.	HDD	Class II	1977-10-27
K771931	Monitor, Dinmap, Model 850	Applied Medical Research	DXN	Class II	1977-10-27
K771930	Emisonic 4500 Tm	Emi Medical, Inc.	IYO	Class II	1977-10-27
K771878	Iridium 192 Wires & Pins	Cis Radiopharmaceuticals, Inc.	IWA	Class II	1977-10-27
K771851	Arthroscope Operative Knife Set	Richard Wolf Medical Instruments Corp.	HTS	Class I	1977-10-27
K771409	Disp. Surgical Face Mask	Precept, Inc.	FXX	Class II	1977-10-27
K770970	Hair Transplant Punch, Multiplh	Padgett Instruments, Inc.	GAH	Class I	1977-10-27
K771964	8Mm Trocar & Cannual W/stopcock	Kli	HET	Class II	1977-10-25
K771963	Single Incision Tubal Occlu. Band Appl.	Kli	HET	Class II	1977-10-25
K771961	Dual Incision Tubal Occlus. Band Appli.	Kli	HET	Class II	1977-10-25
K771960	Tubal Occlusion Inserter/laparoscope	Kli	HET	Class II	1977-10-25
K771959	8Mm Self-Sealing Trocar & Cannula	Kli	HET	Class II	1977-10-25
K771958	12Mm Self-Sealing Trocar & Cannula	Kli	HET	Class II	1977-10-25