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 2010 of 3531

510(k) clearances, page 2010 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K944493	Reverse Osmosis System	G.E.M. Water Systems	FIP	Class II	1996-02-20
K960402	Buddy Wheelchair	Metro-Care	IOR	Class I	1996-02-16
K960289	James Korea Optical Frames & Sunglasses	James Korea Co., Ltd.	HQY	Class I	1996-02-16
K960066	Immulite Acth	Siemens Healthcare Diagnostics Inc.	CKG	Class II	1996-02-16
K955934	Triage Panel for Drugs of Abuse Model 9500/93000	Biosite Incorporated	DKZ	Class II	1996-02-16
K955921	A549 Cell Culture	Viratest Intl., Inc.	KIR	Class I	1996-02-16
K955856	Tex-Aid Blue	Abbott Medical	LKY	Class II	1996-02-16
K955758	Indigo Medical Model Idl 830E	Indigo Medical, Inc.	GEX	Class II	1996-02-16
K955716	Vancomycin Fpia Reagent Set	Sigma Diagnostics, Inc.	LEH	Class II	1996-02-16
K955644	Synchron Systems Carbamazepine Test System	Beckman Instruments, Inc.	KLT	Class II	1996-02-16
K955473	Gamma System	Zimmer GmbH	JDI	Class II	1996-02-16
K955376	Immulite Hgh	Siemens Healthcare Diagnostics Inc.	CFL	Class I	1996-02-16
K955350	Bimetric Cocr Head/neck Replacement Hip Stem	Zimmer GmbH	LZO	Class II	1996-02-16
K955348	Titanium Moss Miami Spinal System	Depuy, Inc.	KWP	Class II	1996-02-16
K955347	Ultraflex	Boston Scientific Corporation	ESW	Class II	1996-02-16
K955277	Arterial Blood Tubing Set for Single Needle Hemodialysis	Baxter Healthcare Corporation	KOC	Class II	1996-02-16
K955156	Wako Autokit Crp New	FUJIFILM Healthcare Americas Corporation	DCK	Class II	1996-02-16
K955129	Oxypulse Eoc I, Eoc II & Eoc R	Eagle Medical Equipment Co.	NFB	Class II	1996-02-16
K954986	Gc Base W/ 1% Gchi	Remel Inc	JTY	Class II	1996-02-16
K954930	Bactec Culture Vials, Lytic, Anaerobic	Becton Dickinson Diagnostic Instrument Systems	MDB	Class I	1996-02-16
K954927	Bactec Peds Plus/f Culture Vials	Becton Dickinson Diagnostic Instrument Systems	MDB	Class I	1996-02-16
K954925	Bactec Lytic/10 Anaerobic/f Culture Vials	Becton Dickinson Diagnostic Instrument Systems	MDB	Class I	1996-02-16
K954921	Bactec Standard/10 Aerobic/f Culture Vials	Becton Dickinson Diagnostic Instrument Systems	MDB	Class I	1996-02-16
K953851	Ceralas F Nd:yag Laser System	Ceram Optec, Inc.	GEX	Class II	1996-02-16
K952852	Nima (Needleless Injectionsite Master Adapter) & i.v. Set	Critical Device Corp.	FPA	Class II	1996-02-16
K950666	Unique Needle with Firm Grip Shield	Unique Management Ent., Inc.	FMF	Class II	1996-02-16
K942389	Trocars, Trocar Sleeves and Reduction Sleeves	Hogan & Hartson	HET	Class II	1996-02-16
K955935	Triage Panel for Drugs of Abuse/tricyclic Antidepressants	Biosite Incorporated	DKZ	Class II	1996-02-15
K955806	Howmedica Bioabsorbable Pin	Howmedica Corp.	HTY	Class II	1996-02-15
K954854	Intermoore Fracture Hip Stem	Intermedics Orthopedics	LWJ	Class II	1996-02-15
K954833	Accu-Chek Advantage Test Strips	Boehringer Mannheim Corp.	LFR	Class II	1996-02-15
K954246	Acufex Endofix Absorbable Interference Screw	Acufex Microsurgical, Inc.	HWC	Class II	1996-02-15
K953915	Moss Miami Spinal System (Anterior Use)	Depuy, Inc.	MNH	Class II	1996-02-15
K953898	Acl-5500 Precision Curing Unit (Pcu)	Ion Laser Technology	EBZ	Class II	1996-02-15
K953751	Biologic-Dt System	Hemocleanse, Inc.	FLD	Class II	1996-02-15
K951822	Ebna Enzyme Immunoassay Kit	Granbio, Inc.	LLM	Class I	1996-02-15
K951221	Total CO2	Randox Laboratories, Limited	KHS	Class II	1996-02-15
K960226	Dg 88	Degussa AG	EJT	Class II	1996-02-14
K960067	Immilite Total Ige	Siemens Healthcare Diagnostics Inc.	JHR	Class II	1996-02-14
K960063	Bosworth Impression Material I	Harry J. Bosworth Co.	ELW	Class II	1996-02-14
K955868	Boehringer Mannheim Cardiac T Tropnin T	Boehringer Mannheim Corp.	MMI	Class II	1996-02-14
K955793	Il Bgge Blood Gas with Glucose System	Instrumentation Laboratory Co.	CHL	Class II	1996-02-14
K955729	Lactosorb Trauma Plating System	Poly-Medics,Inc.	HRS	Class II	1996-02-14
K955640	Lorenz Mandibular Distractor	Zimmer GmbH	MQN	Class II	1996-02-14
K955528	Clp Bonnet	Clp Products	DZB	Class II	1996-02-14
K955349	Hemashield Knitted Double Velour Cardiovascular Fabric	Meadox Medicals, Div. Boston Scientific Corp.	DXZ	Class II	1996-02-14
K955296	Link Mp Reconstruction Hip	Link America, Inc.	JDI	Class II	1996-02-14
K954665	Glycar Staple Strips	Glycar SA Pty., Ltd.	FTL	Class II	1996-02-14
K954652	Aesculap Endosccopic Spine Instruments	Aesculap Inc	HRX	Class II	1996-02-14
K954537	Olympus C-Reactive Protein Immunoturbidimetric Reagent	OLYMPUS Corporation of the Americas	DCN	Class II	1996-02-14