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 2026-11-02, 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 2470 of 3531

510(k) clearances, page 2470 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K910722	450Cm Guide Wire for G.i. Use	Terumo Corp.	OCY	Class II	1991-03-21
K910713	Flynn Tissue Probe and Blunt Dissector	Marlo Surgical Technology	HET	Class II	1991-03-21
K910695	Auto Sash (Tm)	Block Medical, Inc.	FPA	Class II	1991-03-21
K910642	Cedia(r) Digoxin Sc Assay	Microgenics Corporation	KXT	Class II	1991-03-21
K910583	u.s. Medical Ps-3000 Neonatal Scale	U.S. Medical Corp.	FRW	Class I	1991-03-21
K910582	u.s. Medical Ps-2000 Pediatric Scale	U.S. Medical Corp.	FRW	Class I	1991-03-21
K910581	u.s. Medical Ps-1000 Pediatric Scale	U.S. Medical Corp.	FRW	Class I	1991-03-21
K910523	Modified Volumetric Infusion Pumps Attachments	Baxter Healthcare Corporation	FRN	Class II	1991-03-21
K910468	Sterile Disposable Drape(s)	E.M. Adams Co., Inc.	FZI	Class II	1991-03-21
K910441	Floscope Microdop	Advance Medical Device, Inc.	DPT	Class II	1991-03-21
K910351	Miniclinic Ovulation Prediction Test	Vanguard Biomedical Corp.	CEP	Class I	1991-03-21
K910349	Immunocorp Coated Tube Irma Hcg	Immunocorp	JHI	Class II	1991-03-21
K910008	Endothred Adjustable Stabilitly Theread	Ethicon, Inc	HET	Class II	1991-03-21
K905826	Isola Slotted Connect/angled Slotted Connector	Acromed Corp.	KWP	Class II	1991-03-21
K905738	Operative Cholangiographic Catheter	Applied Vascular Devices, Inc.	FGE	Class II	1991-03-21
K905489	Ver-Med A10017 Universal Electrode	Vermont Medical, Inc.	DRX	Class II	1991-03-21
K905385	P.i.v. Complement-Fixation (C.f.) Antigen	Virion (U.S.), Inc.	GQS	Class I	1991-03-21
K904930	Surgical Carbon Dioxide Laser Syst Model 20-Ch	Directed Energy, Inc.	GEX	Class II	1991-03-21
K904709	Bc 1213 Healing Screw	Minimatic Implant Technology	DZE	Class II	1991-03-21
K904708	Bc 1211 Abutment, Fixed Transfer Pin, Indirect	Minimatic Implant Technology	DZE	Class II	1991-03-21
K904706	Bc 1207 Abutment Fixed	Minimatic Implant Technology	DZE	Class II	1991-03-21
K904704	Bc 1203 Abutment Tapered Shoulder	Minimatic Implant Technology	DZE	Class II	1991-03-21
K904668	Ie Magnetic Extractor	Olympus Corp.	FCC	Class II	1991-03-21
K904624	Expandacel Nasal Tampons	Ron Shippert, MD	EMX	Class I	1991-03-21
K904613	Trichinella Serology Microtiter Elisa	Lmd Laboratories	GPG	Class I	1991-03-21
K904547	Stethoscope	Kimball Industries Co., Ltd.	LDE	Class I	1991-03-21
K904017	Siemens Sonoline Si-450, Ob/gyn,ent,dental Devices	Siemens Ultrasound, Inc.	IYN	Class II	1991-03-21
K910383	Hpi Sensi-Shield Glove Kit	Hpi, Inc.	KGO	Class I	1991-03-20
K910271	Vacpac Portable Aspiration System	JEDMED Instrument Company	BTA	Class II	1991-03-20
K910110	Triple Layer Fluid-Resistant Molded Face Mask	3M Company	FXX	Class II	1991-03-20
K910080	Kaltostat Wound Packing	Calgon Vestal Div.	QSY	Unclassified	1991-03-20
K910059	Kaltostat Wound Dressing	Calgon Vestal Div.	QSY	Unclassified	1991-03-20
K910003	Cytomegalovirus Antibody Screen	Immucor, Inc.	LJO	Class II	1991-03-20
K905614	Jackson-Pratt, High Lubricity and Wound Drains	Baxter Healthcare Corporation	GBX	Class I	1991-03-20
K910875	Endopath Disposable Pneumoperitoneum Needle	Ethicon, Inc	FDP	Class II	1991-03-19
K910768	Surgitek(r) 420 Cm G.i. Infusion Guidewire	Surgitek Medical Engineering Corp.	FGE	Class II	1991-03-19
K910738	Target Amphetamine/methamphetamine-V (Visual Meth)	V-Tech, Inc.	DKZ	Class II	1991-03-19
K910717	Pantex Irma Lh 1251 Kit	Pantex, Div. Bio-Analysis, Inc.	CEP	Class I	1991-03-19
K910686	Rheumajet Crp	Biokit USA, Inc.	DCN	Class II	1991-03-19
K910668	Ortho* Chlamydia Antigen Elisa Test/modification	Ortho Diagnostic Systems, Inc.	LJC	Class I	1991-03-19
K910644	Ipazyme (Tm) Chlamydia Igg-Iga	Savyon Diagnostics Ltd.	LKH	Class I	1991-03-19
K910514	Model 3150-21 Quadrature Spine Coil in Positioner	Medical Advances, Inc.	LNH	Class II	1991-03-19
K910513	Model 3150-64 Quadrature Spine Coil in Positioner	Medical Advances, Inc.	LNH	Class II	1991-03-19
K910436	Elastic Adhesive Bandage	Byron Medical	KGX	Class I	1991-03-19
K910332	Flexiflo Sacks-Vine Gastrostomy Kits	Abbott Medical	KNT	Class II	1991-03-19
K910286	Platelet Aggregation Reagents	Medical Diagnostic Technologies, Inc.	GHR	Class II	1991-03-19
K910223	Cpi Model 2215/Seamed Model 3400	Seamed Corp.	DTC	Class II	1991-03-19
K910123	Target Cocaine Metabolite-V	V-Tech, Inc.	KLN	Class II	1991-03-19
K910122	Target Cocaine Metabolite-R	V-Tech, Inc.	KLN	Class II	1991-03-19
K910117	Reddick Irrigation/aspiration System	Ideal Medical, Inc.	GAA	Class I	1991-03-19