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 2017 of 3531

510(k) clearances, page 2017 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955120	Hand-Held Retractor, Dissector & Dissector	Ethicon Endo-Surgery Inc	GCM	Class II	1996-01-26
K955014	Applied Optronics Model Aoc 25 Surgical Diode	Applied Optronics Corp.	GEX	Class II	1996-01-26
K955007	Applied Optronics Model Aoc 5060 Surgfical Diode Laser System	Applied Optronics Corp.	GEX	Class II	1996-01-26
K955000	Remote Viewing System Medical Image Display Module	Cerner Corporation	LMD	Class I	1996-01-26
K954990	Dental Dam	The Hygenic Company, LLC	EIE	Class I	1996-01-26
K954684	Depuy Anatomic Modular Knee (Amk) Congruency Posterior Stabilized Tibial Insert	Depuy, Inc.	JWH	Class II	1996-01-26
K954555	Versa-Fx Femoral Fixation System	Zimmer GmbH	KTT	Class II	1996-01-26
K954285	Contour Flex Valves (Regular & Small)	Radionics, Inc.	JXG	Class II	1996-01-26
K954186	Sled Unicompartment Knee System	Link America, Inc.	HSX	Class II	1996-01-26
K954153	Arista Vinyl Examination Gloves	Arista Latindo Industrial, Ltd. P.T.	LYZ	Class I	1996-01-26
K953977	Primaloc Cementless Hip System	Ortho Development Corp.	KWY	Class II	1996-01-26
K953754	Global Healthcare Face Mask	Global Healthcare, Inc.	FXX	Class II	1996-01-26
K953746	Arrow High Flow Fluid Adminsitration Set W/blood Filter & Extension Set	Arrow Intl., Inc.	FPA	Class II	1996-01-26
K953670	Accuscan Model C CO2 Laser Scanner	Reliant Technologies, Inc.	GEX	Class II	1996-01-26
K953587	Varelisa Mpo-Anca	Elias U.S.A., Inc.	MOB	Class II	1996-01-26
K953586	Varelisa Pr3-Anca	Elias U.S.A., Inc.	MOB	Class II	1996-01-26
K953583	Lubricated Condom	Tactyl Technologies, Inc.	HIS	Class II	1996-01-26
K953529	Strato/infusaid Life & Infuse-a-Port Implantable Port System	Strato/Infusaid, Inc.	LJT	Class II	1996-01-26
K953456	E-Z Flex	Fluid Motion Biotechnologies, Inc.	BXB	Class I	1996-01-26
K953250	Senographe Pearl and Senographe Sapphire	GE Healthcare	IZH	Class II	1996-01-26
K952819	Abbott Testpack Plus Strep a with on Board Controls (Obc)	Abbott Medical	GTZ	Class I	1996-01-26
K952294	Neuronet	Computational Diagnostics, Inc.	GWF	Class II	1996-01-26
K950518	Miele G 7781 Dental Thermal Disinfector	Miele Professional	LDS	Class II	1996-01-26
K945212	Monoclonal Mouse Anti-Human T-Cell, Cd4, Clone Mt310, Fitc-Conjugated, (Anti-Cd4/fitc, Mt310) Rpe-Conjugated, (Anti-Cd4/	Dako Corp.	GKZ	Class II	1996-01-26
K944544	Absorbable Bone Screw	Johnson & Johnson Professionals, Inc.	MAI	Class II	1996-01-26
K943547	Phenylalanine Test Kit	Isolab, Inc.	JNB	Class II	1996-01-26
K955658	Laceration Tray	Transidyne General Corp.	FRG	Class II	1996-01-25
K955284	Opus Troponin I	Behring Diagnostics, Inc.	MMI	Class II	1996-01-25
K955066	Olympus Fg Series Grasping Forceps	OLYMPUS Corporation of the Americas	OCZ	Class II	1996-01-25
K954992	Roche Cobas Integra Reagent Cassettes	Roche Diagnostic Systems, Inc.	CIT	Class II	1996-01-25
K954954	Ceegraph Traveler Ambulatory EEG Recorder	Bio-Logic Systems Corp.	GWQ	Class II	1996-01-25
K954942	Natracaren Applicator Tampon	Bodywise (UK) Ltd.	HEB	Class II	1996-01-25
K954939	Medpor Ocular Screw & Accessories	Porex Surgical, Inc.	HPZ	Class II	1996-01-25
K954804	Lung Diffusion Mixtures	Mittler Supply, Inc.	BXK	Class I	1996-01-25
K954803	Blood Gas Mixtures	Mittler Supply, Inc.	BXK	Class I	1996-01-25
K954801	Techfil	Technimeca Medic, Inc.	CAD	Class II	1996-01-25
K954770	Centra-Line Grapple, Varifix System	Advanced Spine Fixation Systems, Inc.	KWP	Class II	1996-01-25
K954757	Fixano D.d.s. (Double Sliding Screw)	Ferguson Medical	HWC	Class II	1996-01-25
K954756	Fixano I.f.o (Interlocking Flexible Osteosynthesis) System	Ferguson Medical	HSB	Class II	1996-01-25
K954352	Bite Block	United States Endoscopy Group, Inc.	JXL	Class II	1996-01-25
K954195	Indigo Portable Laser System, Inddigo Fiberoptics	Indigo Medical, Inc.	GEX	Class II	1996-01-25
K954016	Videoscope W/irrigation Sheath	T. Korossurgical Instruments Corp.	HRX	Class II	1996-01-25
K953748	Technofil	Technimeca Medic, Inc.	CAD	Class II	1996-01-25
K951044	System One Hyperbaric Chamber	Nth Systems, Inc.	CBF	Class II	1996-01-25
K950999	Ksf Posterior Spingal Fixator for Severe Spondylolisthesis	Buckman Co., Inc.	MNH	Class II	1996-01-25
K945303	Arthrex Bioabsorbable Interference Screw	Arthrex GmbH	HWC	Class II	1996-01-25
K945068	Omega Cares System	J-F Medical Systems Intl., Inc.	DQK	Class II	1996-01-25
K955810	U-Tex	Abbott Medical	FHA	Class I	1996-01-24
K955567	Innofluor Theophylline Assay System	Oxis Intl., Inc.	LGS	Class II	1996-01-24
K955562	Innofluor Phenytoin Assay System	Oxis Intl., Inc.	LGR	Class II	1996-01-24