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 2430 of 3531

510(k) clearances, page 2430 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K912141	Volumetric Pump Solution Set Modified Cassette	Baxter Healthcare Corporation	FPA	Class II	1991-09-11
K911414	Cvis Insight Imaging Catheters	Cardiovascular Imaging Systems, Inc.	ITX	Class II	1991-09-11
K911379	Danek Sacral Hook, Modification	Danek Medical, Inc.	KWP	Class II	1991-09-11
K911308	Cardiotrace-I Transtelephonic ECG Receiv Console	Medical Equipment Designs, Inc.	DXH	Class II	1991-09-11
K913739	Il Test(tm) Dat Calibrator a( -)	Instrumentation Laboratory Co.	DKB	Class II	1991-09-10
K913722	Abuscreen(r) Radioimmun for Cocaine Metabolite	Roche Diagnostic Systems, Inc.	KLN	Class II	1991-09-10
K913493	Aia-Pack Ft4	Tosoh Corp.	CEC	Class II	1991-09-10
K913488	Sti Contact 200 Fiberoptic Delivery System	Sunrise Technologies, Inc.	GEX	Class II	1991-09-10
K912955	Eye Pad	Cal West Trading Co.	EFQ	Unclassified	1991-09-10
K912954	Stretch Gauze Bandage	Cal West Trading Co.	NAB	Class I	1991-09-10
K912951	12-Ply Gauze Pad	Cal West Trading Co.	NAB	Class I	1991-09-10
K912732	First Choice(tm)	Polymer Technology Corp.	CGA	Class II	1991-09-10
K912679	Dade(r) Immunoadsorbed Fact V Def Plasma (Human)	Baxter Healthcare Corporation	GJT	Class II	1991-09-10
K912627	Midas System 2500, Physiological Monitoring System	Ppg Industries, Inc.	MHX	Class II	1991-09-10
K912549	Bard(r) Disposable Biopsy Forceps	C.R. Bard Inc	FCL	Class I	1991-09-10
K912494	Sysmex(tm) R-3000 Automated Reticulocyte Analyzer	Toa Medical Electronics USA, Inc.	GKL	Class II	1991-09-10
K912407	Cox Disposable Cytology Brushes	Cox Medical Ent., Inc.	FDX	Class II	1991-09-10
K911959	Signa Advantage Magnetic Resonance System M1090gf	GE Healthcare	LNH	Class II	1991-09-10
K911881	Dsl Beta 2 Microglobulin (Dsl 6200)	Diagnostic Systems Laboratories, Inc.	JZG	Class II	1991-09-10
K911819	Acra-Cut Neurological Surgical Device-Powered	Acra Cut, Inc.	HBE	Class II	1991-09-10
K911812	Acra-Cut Wire Pass Drill	Acra Cut, Inc.	HBE	Class II	1991-09-10
K911759	Vortran Intermittent Signal Activated Nebulizer	Vortran Medical Technology 1, Inc	CAF	Class II	1991-09-10
K911723	Codman Disposable Skull Pins	Cerenovus, Inc.	HBL	Class II	1991-09-10
K911306	T-Bolt and Nut	Danek Medical, Inc.	HTN	Class II	1991-09-10
K910940	Anatomic Modular Knee Polyethylene Tibial Tray	Depuy, Inc.	JWH	Class II	1991-09-10
K910643	Casio Bp-100	Casio, Inc.	DXN	Class II	1991-09-10
K905860	Heyer-Schulte Spinal Cyst Catheter/modification	Baxter Healthcare Corporation	JXG	Class II	1991-09-10
K904924	Infusa Pu Syringe Infusion Pump	Ferguson Medical	FRN	Class II	1991-09-10
K904181	Anti-Gbm Antibodies Quantitative Kit	Biochemical Diagnostic, Inc.	DBL	Class II	1991-09-10
K901732	EMG Accessory for Posturography	Neurocom International, Inc.	IKN	Class II	1991-09-10
K912556	Davis and Geck Lapro-Loop Ligature Carrier	Davis & Geck, Inc.	GCJ	Class II	1991-09-09
K912554	Annuloplasty Rings, Model 4400 Mirtal and 4500 Tri	Baxter Healthcare Corporation	KRH	Class II	1991-09-09
K911583	Ionos(r) Ossicle 5Mm & 7Mm	Ionos GmbH & Co. KG	ETA	Class II	1991-09-09
K910902	Vmx Mobile X-Ray System	GE Healthcare	IZL	Class II	1991-09-09
K913650	Drug Testing Assessment Program Quality Control	Duo Research, Inc.	DIF	Class I	1991-09-06
K913575	Gauze Packing, Surgical Sterile and Non-Sterile	Keilei Intl., Inc.	FRO	Unclassified	1991-09-06
K913503	Phonak Pico-Forte Pp-C-P Bte Hearing Instrument	Phonak, Inc.	ESD	Class I	1991-09-06
K913502	Phonak Audinet Pp-C-P Bte Hearing Instrument	Phonak, Inc.	ESD	Class I	1991-09-06
K913491	Vortech's Personal Display System	Vortech Data, Inc.	JAK	Class II	1991-09-06
K913473	E-Z Clean Electrode	Megadyne Medical Products, Inc	GEI	Class II	1991-09-06
K913450	Heart Technology Rotablator Wireclip	Heart Technology, Inc.	MCW	Class II	1991-09-06
K913411	Davis & Geck Valtrac(r) Biofrag Anastomosis Ring	Davis & Geck, Inc.	GDW	Class II	1991-09-06
K913240	Digitoxin (Fpia) Kit	Tudor Laboratories, Inc.	LFM	Class II	1991-09-06
K913232	Ultracrown(tm) Pd Dental Alloy	Dentsply Intl.	EJS	Class II	1991-09-06
K913172	Endoscopic Delivery System	Medco Products, Co., Inc.	GCJ	Class II	1991-09-06
K913170	Codman Skull Clamp	Cerenovus, Inc.	HBL	Class II	1991-09-06
K913168	Salibag	Nix Co., Ltd.	EGZ	Class I	1991-09-06
K913160	Id-Tab	Nix Co., Ltd.	EGZ	Class I	1991-09-06
K913139	Implantable Metal Staples	Ethicon, Inc	GDW	Class II	1991-09-06
K913056	Volumetric Infusion Pump, Modification	Mcgaw, Inc.	FRN	Class II	1991-09-06