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 2023 of 3531

510(k) clearances, page 2023 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K954551	Df-1 Terminal Cap	Pacesetter, Inc.	DTB	Class III	1995-12-26
K954392	Hytec Autoimmune Kit (Ss-a)	Hycor Biomedical	LKJ	Class II	1995-12-26
K953539	Dm001 Disposable Pack	Tenex Health	HQC	Class II	1995-12-26
K953538	Rm001 Reusable	Tenex Health	HQC	Class II	1995-12-26
K953129	Esp Culture System - Myco	Difco Laboratories, Inc.	MDB	Class I	1995-12-26
K952576	Transport Cart	Belmont Medical Technologies	DSP	Class II	1995-12-26
K951223	Ck-Mb (Nac-Act)	Randox Laboratories, Limited	CGS	Class II	1995-12-26
K950621	Biofill Biocellulose Dressing Sterile	The Purdue Frederick Co.	KMF	Class I	1995-12-26
K955615	Misten Medical Total Ossicular Replacement Prosthesis	Misten Medical Corp.	ETA	Class II	1995-12-22
K955613	Misten Medical Partial Ossicular Replacement Prosthesis	Misten Medical Corp.	ETB	Class II	1995-12-22
K955593	Expandacell Anatomical Posterior Nasal Pack W/& without Airway	Summit Medical, LLC	EMX	Class I	1995-12-22
K955574	Resound Personal Hearing System Btp W/dai	Resound Corp.	ESD	Class I	1995-12-22
K955560	Trebay Scope Irrigated Clearing Sleeve	Trebay Medical Corp.	EOB	Class II	1995-12-22
K955516	Montgomery Tracheostomy Speaking Valve	Boston Medical Products, Inc.	JOH	Class II	1995-12-22
K955294	Sof - Abrasion Bur	Trebay Medical Corp.	EQJ	Class I	1995-12-22
K955249	Sensor Pad	Inventive Products, Inc.	IZH	Class II	1995-12-22
K955069	Playskool	Hasbro, Inc.	KKO	Class II	1995-12-22
K955036	Mobile X-Ray System	Shimadzu Corp.	IZL	Class II	1995-12-22
K954949	Transit Infusion Catheter with Sideholes	Cordis Neurovascular, Inc.	KRA	Class II	1995-12-22
K954941	Miracle Ear and Audiotone	Miracle-Ear, Inc.	ESD	Class I	1995-12-22
K954649	Wgl Endoscopic Grasper W/detachable Strap	Wilson Greatbatch Technologies, Inc.	GCJ	Class II	1995-12-22
K954634	Radiosurgery Verification Phantom	Phantom Laboratory	IYE	Class II	1995-12-22
K954601	Nerve Locator/monitor System Modification	Rln Systems, Inc.	ETN	Class II	1995-12-22
K954562	Gynetech P.o.s. Spap Smear Cell Collection & Transport Kit	Gynetech Pty., Ltd.	HHT	Class II	1995-12-22
K954542	Lung Diffusion Mixture	Liquid Technology Corp.	BXK	Class I	1995-12-22
K954519	Wang Transendoscopic Aspiration Needle	Mill-Rose Laboratory	FBK	Class II	1995-12-22
K954383	Sureloc Circuit Connector	Polamedco, Inc.	BZA	Class I	1995-12-22
K954308	Gamp & Assoc. Disposable Aspirating Endoocular Laser Probe	Gamp & Assoc.	HQB	Class II	1995-12-22
K954307	Gamp & Assoc. Disposable Endoocular Laser Probe	Gamp & Assoc.	HQB	Class II	1995-12-22
K954306	Gamp & Assoc. Disposable Ill Endocular Laser Probe	Gamp & Assoc.	HQB	Class II	1995-12-22
K954143	Hitachi Spectradigital Series Gamma Camera Systems	Hitachi Medical Corp. of America	KPS	Class II	1995-12-22
K954129	Spectradigital Series V250dsp	Hitachi Medical Corp. of America	KPS	Class II	1995-12-22
K953997	Rotablator Rotational Angioplasty	Heart Technology Mfg., Inc.	MCW	Class II	1995-12-22
K953942	Cobrascan Cx-312	Radiographic Digital Imaging, Inc.	LMA	Class II	1995-12-22
K953384	Multi Side Hole lnfusion System	Boston Scientific Corporation	QEY	Class II	1995-12-22
K953098	Volumetric Infusion Pump	Baxter Healthcare Corporation	FRN	Class II	1995-12-22
K952889	Insul-Coat/2 Ceramic Coated Endo Medical Instruments	Materials Conversion Corp.	HET	Class II	1995-12-22
K952343	Focua 90R, 90Hr, 120R, 120Hr, 160R, 160Hr Hollow Fiber Dialyzer	National Medical Care, Medical Products Div., Inc.	FJI	Class II	1995-12-22
K951429	Flexiflo 6.1 Enteral Nutrition Pump	Ross Products	LZH	Class II	1995-12-22
K946230	Endura Reusable TENS and Nmes Electrodes	Spectramed, LLC	GZJ	Class II	1995-12-22
K945945	Gyroscan Acs-Nt, Gyroscan T5-Nt and Gyroscan T10-Nt	Philips North America LLC	LNH	Class II	1995-12-22
K943896	Guide Wire for the Use with Datascope Percor Stat-Dl Iabs	Datascope Corp.	DQX	Class II	1995-12-22
K942265	Flexible Nasopharyngo-Laryngoscope and Endosheath	Cogentix Medical, Inc.	EOB	Class II	1995-12-22
K941352	Ssa-340A	Toshiba America Medical Systems, In.C	IYN	Class II	1995-12-22
K955447	Tympanostomy Tube	Trebay Medical Corp.	ETD	Class II	1995-12-21
K955440	Immulite Shbg (Modification)	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	1995-12-21
K955233	Easy Breathing Nasal Strips	Corbett Lair, Inc.	LWF	Class I	1995-12-21
K955095	Sierra Battery Sealed Lead Acid Battery System	Sierra Battery, Inc.	IZL	Class II	1995-12-21
K954860	Echonet	Heartlab, Inc.	LLZ	Class II	1995-12-21
K954807	Cedia T Uptake Assay	Boehringer Mannheim Corp.	KHQ	Class II	1995-12-21