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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2913 of 3529

510(k) clearances, page 2913 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860576	Murex Suds Group a Strep	Murex Corp.	GTZ	Class I	1986-04-04
K860544	Bacstop Filter Irrigation Supply Kit	Staar Surgical AG	KYG	Class I	1986-04-04
K860504	36-101 Xds111 Xenon Delivery/trap System	Victoreen, Inc.	ITY	Class I	1986-04-04
K860483	Filtra-Check-Uti	Applied Polytechnology, Inc.	JXA	Class I	1986-04-04
K860445	Clamp-N-Cut	Mmi, Inc.	HFW	Class II	1986-04-04
K860371	Asserachrom Vwf Kit	American Bioproducts Co.	GGP	Class II	1986-04-04
K860360	Kyocera Bioceram Porous Dental Implant	Kyocera International, Inc.	DZE	Class II	1986-04-04
K860185	Unistim Unt-1M Neurostimulator Transmitter	Neuromed, Inc.	GZB	Class II	1986-04-04
K860178	Kultsure (Culture Transport)	Ncs Diagnostics, Inc.	JSM	Class I	1986-04-04
K860174	Gunkel Chromagraph Color Vision Tester	Chromagraphics, Inc.	HIW	Class I	1986-04-04
K860166	Picoscale Blood Cell Counter, Model Ps-5	Diagnostic Technology, Inc.	GKL	Class II	1986-04-04
K860122	Hemotec Act High Range Activated Clotting Time	Medical Device Consultants, Inc.	JBP	Class II	1986-04-04
K855086	Katalavox Voice-Activated Switching Device	Kempf Co.	ITI	Class II	1986-04-04
K854968	Bausch & Lomb Lens Carrying Case	Bausch & Lomb Incorporated	HPX	Unclassified	1986-04-04
K854833	Mds-83 in Dermatological/plastic Surgery Applicati	Meditec Co., Ltd.	GEX	Class II	1986-04-04
K854685	Digital-9 Key Leucocyte Counter	Future Impex Corp.	GKM	Class I	1986-04-04
K854223	Ves-Tec/ves-Matic	Marvic Interpharma, Inc.	CKB	Class II	1986-04-04
K853501	Honeywell Electronic Ventilator Ev-a	Honeywell, Inc.	CBK	Class II	1986-04-04
K853094	Emperor 5/20 & Std, C.c, Ortho, Psp Refit, Perisea	PSP Dental Co., Ltd.	EBI	Class II	1986-04-04
K861051	Isolife Dispensing System	Navaco Laboratories	KNT	Class II	1986-04-03
K861000	Gilford Uniqual Normal Control Serum/unassayed	Ciba Corning Diagnostics Corp.	JJY	Class I	1986-04-03
K860998	Gilford Uniqual Abnormal Control Serum/unassayed	Ciba Corning Diagnostics Corp.	JJY	Class I	1986-04-03
K860970	Precinorm Im and Precipath Im	Boehringer Mannheim Corp.	JJY	Class I	1986-04-03
K860946	Davis Loop Stone Extractor/ureteral Catheter	Van-Tec, Inc.	FFL	Class II	1986-04-03
K860918	Easy-Test Amlase (Amyl), #67521/93	Em Diagnostic Systems, Inc.	JFJ	Class II	1986-04-03
K860868	Technicon Ra Systems/tobramycin & Gentamicin	Technicon Instruments Corp.	LCD	Class II	1986-04-03
K860799	Analyte Iron/technicon Chem 1 System	Technicon Instruments Corp.	JIY	Class I	1986-04-03
K860671	Dahlberg Model Ef Behind-the-Ear Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1986-04-03
K860667	Aspartate Aminotransferase (Ast/sgot) Reagent Set	Sterling Diagnostics, Inc.	CIT	Class II	1986-04-03
K860641	Easy-Test (Che) Reagent, Item No. 67522/93	Em Diagnostic Systems, Inc.	DLI	Class I	1986-04-03
K860485	Sgpt (Alt) Reagent Set (Colorimetric)	Sterling Diagnostics, Inc.	CKD	Class I	1986-04-03
K860477	Uric Acid Reagnet Set (Trinder)	Sterling Diagnostics, Inc.	KNK	Class I	1986-04-03
K860426	A-Gent Liquid Total Protein	Abbott Medical	CEK	Class II	1986-04-03
K860425	A-Gent Liquid Calcium	Abbott Medical	CIC	Class II	1986-04-03
K860424	A-Gent Liquid Total Bilirubin	Abbott Medical	CIG	Class II	1986-04-03
K860275	Ti-Fit Acetabular Component	Richards Medical Co., Inc.	LZO	Class II	1986-04-03
K860268	Van-Tec Deflecting Grasping Forceps	Van-Tec, Inc.	FFL	Class II	1986-04-03
K860267	Mardis Dangler Ureteral Stent Set	Van-Tec, Inc.	FAD	Class II	1986-04-03
K860216	Sgot (Ast) Reagent Set	Sterling Diagnostics, Inc.	CIQ	Class II	1986-04-03
K855059	Audiant Bone Conductor or A.b.c.	Xomed, Inc.	LXB	Class II	1986-04-03
K853092	Psp C & B Temp	PSP Dental Co., Ltd.	EBG	Class II	1986-04-03
K861088	Bivona Economy Duckbill Voice Prosthesis	Bivona Medical Technologies	EWL	Class II	1986-04-02
K861050	Biopsy Adapter H4222w	General Electric Co.	GDF	Class I	1986-04-02
K861019	Ceiling Mount Counterpoised Secon Radiation Shield	Phase One Disign Co.	EAK	Class I	1986-04-02
K860941	Disposable Heated Wire Loops 48 and 72	Intec Medical, Inc.	BZE	Class II	1986-04-02
K860844	Vista Interface Sysstem	Vacumetrics, Inc.	BZC	Class II	1986-04-02
K860802	Tracheobronchial Suction Catheter	Sheridan Catheter Corp.	BSY	Class I	1986-04-02
K860780	Plastic Mouth Barrier HCV-E	Westmark Enterprises, Inc.	CAE	Class I	1986-04-02
K860779	Ultraprox, Interproximal Toothbrush	William J. Forni, D.D.S.	JET	Class I	1986-04-02
K860699	Right Atrial Catheter Catalog No. Rac - Xxx Series	Intracath, Inc.	DQY	Class II	1986-04-02