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 2103 of 3531

510(k) clearances, page 2103 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951251	Karl Storz Puncture, Injection, Endoscopic, Veress Needle	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1995-04-03
K951006	Kenex Mobile Cassett Holder (as Exhibit #7)	Kenex, Ltd.	IXA	Class II	1995-04-03
K951003	Kenex Radiation Shield (Various Models as Exhibits #2 & 5)	Kenex, Ltd.	KPY	Class I	1995-04-03
K950981	Ultra-Pro Ultrasound Scanning Table Model #056-650	Sport Medical Technology Inc	IXR	Class II	1995-04-03
K950883	Polydoros Sx 65 and 80	Siemens Medical Solutions USA, Inc.	IZO	Class I	1995-04-03
K950775	Curasorb Zn Alginate Wound Dressing	Kendall Healthcare Products Co. Div.Of Tyco Health	KMF	Class I	1995-04-03
K950192	Skytron Skyboom Series	Skytron, LLC	FQO	Class I	1995-04-03
K950072	Immulite(r) Tbg	Siemens Healthcare Diagnostics Inc.	JJX	Class I	1995-04-03
K950019	Thermolase Lt-100 Nd:yag Laser Hair Removal System; Thermolase Lt-100;Lt-100	Thermolase Corp.	GEX	Class II	1995-04-03
K946199	Auraflex(r) Estradiol	bioMerieux, Inc.	CHP	Class I	1995-04-03
K946104	Smokievac Electrosurgical Pencil	Aspen Laboratories, Inc.	GEI	Class II	1995-04-03
K945962	Bennett X-Ray Profile Positioning Paddle for Mammography	Bennett X-Ray Corp.	IZH	Class II	1995-04-03
K945224	Grx Foam Dressing	Geritrex Corp.	KMF	Class I	1995-04-03
K944309	M.e.r. Surgical Co. Omni Instrument System	M.E.R. Surgical Co.	GCJ	Class II	1995-04-03
K942245	Biowhittaker 2001 Microplate Reader Firmware	Biowhittaker Molecular Applications, Inc.	JJQ	Class I	1995-04-03
K951111	Restore Self Tapping Dental Implant System (3.4Mm)	Lifecore Biomedical LLC	DZE	Class II	1995-03-31
K951075	S & C Vinyl Polysiloxane Impression Material	S & C Polymer GmbH	ELW	Class II	1995-03-31
K951045	Laser Gas Mixture	Liquid Carbonic Industrial Gases	GEX	Class II	1995-03-31
K950965	Karl Storz Stent Applicator Forceps	Karl Storz Endoscopy-America, Inc.	EOQ	Class II	1995-03-31
K950894	Surefire Pf+ (High Palladium Dental Casting Alloy for Porcelain Applications)	Argen Precious Metals, Inc.	EJH	Class II	1995-03-31
K950773	Prophylaxis Pack	Transidyne General Corp.	EGS	Class I	1995-03-31
K950759	Unitron Model Esteem	Unitron Industries, Inc.	ESD	Class I	1995-03-31
K950743	Oral Procedure Pack	Transidyne General Corp.	EGS	Class I	1995-03-31
K950694	Compact-X	Electromed Intl., Ltd.	IZO	Class I	1995-03-31
K950693	Miracle-Ear Model Pm1/pm2 Programmable Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1995-03-31
K950692	Miracle-Ear Model Pbs Programmable Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1995-03-31
K950691	Miracle-Ear Model Pbm Programmable Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1995-03-31
K950571	Linear Fr Tomographic System: 0Mt 8000, Model No. 6681.270	Continental X-Ray Corp.	IZF	Class II	1995-03-31
K950458	Silver Ultra Mini Canal	Electone, Inc.	ESD	Class I	1995-03-31
K950442	Infrared Exposure Hand Switch	Medical X-Ray Intl., Inc.	KXJ	Class II	1995-03-31
K950402	Corsini 9090	C.A.T. di Corsini G. & C. SpA	IXR	Class II	1995-03-31
K950254	Cypress Medical Products Sterile Latex Examination Glove	Cypress Medical Products LLC	LYY	Class I	1995-03-31
K950141	Scimed(r) Choice(tm) Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1995-03-31
K950113	Scimed(r) Chice(tm) Exchange Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1995-03-31
K950021	Reusable Trocar with Safety Sleeve	L.A.S.E.R., Inc.	GCJ	Class II	1995-03-31
K946356	M-Path Nitinol Guidewire	Microvena Corp.	DQX	Class II	1995-03-31
K946282	Universal Urethral Catheter	Louisville Laboratories, Inc.	EZC	Class II	1995-03-31
K946260	Ntbs-1417, 1436, Tbs-1417	Scott Imaging Intl., Inc.	IXY	Class I	1995-03-31
K946240	Scimed(r) Sceptor(tm) Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1995-03-31
K946053	Simview(tm) 3000	Siemens Medical Solutions USA, Inc.	KPQ	Class II	1995-03-31
K945743	Preference Mammography System	Philips North America LLC	IZH	Class II	1995-03-31
K945652	Attenuation Correction	GE Healthcare	KPS	Class II	1995-03-31
K945370	C-Post	Bisco, Inc.	ELR	Class I	1995-03-31
K945241	Lorad M-IV, Lorad M-Ivi	Lorad Corp.	IZH	Class II	1995-03-31
K944873	Triflex Non-Sterile Synthitic Examination Gloves	Baxter Healthcare Corporation	LYZ	Class I	1995-03-31
K944844	Baxter Reinforced Expanded PTFE Stepped Vascular Graft	Baxter Healthcare Corporation	DYF	Class II	1995-03-31
K944685	Cato First Picc-Dual Lumen	Catco Medical, Inc.	LJS	Class II	1995-03-31
K944504	Catco First Picc	Catco Medical, Inc.	FOZ	Class II	1995-03-31
K942411	R-Med Disposable Plug	R-Med, Inc.	HET	Class II	1995-03-31
K941353	Mam-Ch22s Mammography System with Optional Mammoguide Steriotactic Biopsy System	Elscint, Inc.	IZH	Class II	1995-03-31