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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1735 of 3531

510(k) clearances, page 1735 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990342	Synocta Prosthetics	Straumann USA, LLC	DZE	Class II	1999-07-20
K984180	The Aptus (Automated) Application of the Rubella Igm Elisa Test System	Zeus Scientific LLC	LFX	Class II	1999-07-20
K991863	Cute-Lite I Light Cure Unit	Rolence Enterprise Co., Ltd.	EBZ	Class II	1999-07-19
K991827	Ginram Specuvag, Ginram Specuvag as, Ginram Cuscovag, Models 720101, 720102, 720103, 720179, 720227, 720043	Ri Mos. S.r.l.	HIB	Class II	1999-07-19
K991700	Swemed Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes; Holding Pipttes; Denuding Pipettes; Assisted/zo	Swemed Lab International AB	MQH	Class II	1999-07-19
K991568	Mr Spectroscopy Package	Philips North America LLC	LNI	Class II	1999-07-19
K991408	Forma Scientific Universal Water-Jacketed Incubator	Thermoquest Corp.	MQG	Class II	1999-07-19
K991367	Meditron Stethoscope System	Meditron AS	DQD	Class II	1999-07-19
K991173	<Genx> Fertilization Media-Htf	<Genx> Intl., Inc.	MQL	Class II	1999-07-19
K991104	Microtools	Conception Technology, Inc.	MQH	Class II	1999-07-19
K990597	Summer's Eve Lubricating Jelly	C.B. Fleet Co., Inc.	HIS	Class II	1999-07-19
K991727	Stat Profile M7 Analyzer	Nova Biomedical Corporation	CGL	Class II	1999-07-16
K991514	Gebauer's Chloride Fine Nozze	Gebauer Co	MLY	Unclassified	1999-07-16
K991403	Solo-Care Brand Multi-Purpose Solution	Alcon Laboratories	LPN	Class II	1999-07-16
K992122	Tru-Touch Pf Vinyl Powder Free Examination Glove	Maxxim Medical	LYZ	Class I	1999-07-15
K991705	N Protein Standard Uy	Siemens Healthcare Diagnostics Inc.	JIT	Class II	1999-07-15
K991695	Dynarex Non-Woven Sponge	Dynarex Corp.	KMF	Class I	1999-07-15
K991694	Dynarex Drain Sponge	Dynarex Corp.	KMF	Class I	1999-07-15
K991490	Alginate Impression Material II (Fast & Regular Set)	Harry J. Bosworth Co.	ELW	Class II	1999-07-15
K991489	Alginate Impression Material I (Fast & Regular Set)	Harry J. Bosworth Co.	ELW	Class II	1999-07-15
K991389	Anorectal Manometry Suite, Model 9032S0201	Medtronic Functional Diagnostics A/S	FFX	Class II	1999-07-15
K991382	Shieldedtrocar/cannula System, Model 101-005-101	Genicon, LC	GCJ	Class II	1999-07-15
K991001	Modification of Procath Electrophysiology Catheter, Ep Medsystems Electrophysiology Catheter	Abbott Medical	DRF	Class II	1999-07-15
K990822	Rapidone - Cocaine Test	American Bio Medica Corp.	DIO	Class II	1999-07-15
K990820	Rapidone - Opiates Test	American Bio Medica Corp.	DJG	Class II	1999-07-15
K990681	Dbset Multidrug Screen Test Kit	Ameritek, Inc.	DKZ	Class II	1999-07-15
K990524	E9000 System	Linvatec Corporation	HRX	Class II	1999-07-15
K990304	Modification to Astra Tech Implant - Dental System	Astra Tech, Inc.	DZE	Class II	1999-07-15
K984528	Parker Flex-Tip Tracheal Tube	Parker Medical Assoc.	BTR	Class II	1999-07-15
K983940	Ez-Intro Percutaneous Catheter Sheath, Ez-Intro Vessel Dilator	Adam Spence Corp.	DYB	Class II	1999-07-15
K992151	Reference Material for Delta-9-Thc-Cooh in Human Urine	Consolidated Technologies, Inc.	LAS	Class I	1999-07-14
K991869	Cobrex Hip Stem, Model 01-128-Xxxxx	Implex Corp.	JDI	Class II	1999-07-14
K991649	Depuy Rockwood Clavicle Pin	Depuy, Inc.	JDW	Class II	1999-07-14
K991622	26 Mm Cast Cocr Head and Polyethylene Acetabular Shell Liner	Globus Medical, Inc.	JDI	Class II	1999-07-14
K991616	Chlorinated Powder-Free Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)	Hartalega Sdn Bhd	LYY	Class I	1999-07-14
K991567	Shelhigh No-React Tissue Repair Patch/uropatch.	Shelhigh, Inc.	FTM	Class II	1999-07-14
K991509	Pro-Portion Cleaner/disinfectant	Sultan Chemists, Inc.	LRJ	Class I	1999-07-14
K991500	Smith & Nephew Suture Lok	Smith & Nephew Endoscopy, Inc.	OCW	Class II	1999-07-14
K991477	Spin Snap-Off Screw	New Deal, S.A.	HWC	Class II	1999-07-14
K991343	Pvp (Polyvinylpyrrolidone)	FUJIFILM Biosciences Inc.	MQL	Class II	1999-07-14
K991338	Bovine Serum Albumin (Bsa)	FUJIFILM Biosciences Inc.	MQL	Class II	1999-07-14
K991291	Stretta Inflatable Basket Catheter Electrode with Aspiration	Conway Stuart Medical, Inc.	GEI	Class II	1999-07-14
K991114	Regular Diameter Single Stage (Rds) Tps Dental Implant System	Lifecore Biomedical LLC	DZE	Class II	1999-07-14
K990941	Newlife Dish (Etched or Non-Etched, with or without Lid), Models 14-52, 1452E, 1452El, 1452L	CooperSurgical, Inc.	MQK	Class II	1999-07-14
K990847	Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M	CooperSurgical, Inc.	MQH	Class II	1999-07-14
K990341	Electro Mechanical Lithotriptor	Northgate Technologies Inc.	FFK	Class II	1999-07-14
K990068	Solar 9500 Information Monitor	General Electric Medical Systems Information Techn	MHX	Class II	1999-07-14
K984563	The Cyberknife System for Stereotactic Radiosurgery/radiotherapy	Accuray Incorporated	IWB	Class II	1999-07-14
K983660	Exactrac (Brainlab Patient Positioning System)	Brainlab, Inc.	LHN	Class II	1999-07-14
K980380	Neurotrend Multiparameter Sensor, C7004s, to Operate with Paratrend 7+ Multiparameter Sensor, Mpm7001s, and Satellite Ms	Diametrics Medical, Inc.	GWM	Class II	1999-07-14