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 1933 of 3531

510(k) clearances, page 1933 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955393	Numo Nm-1000 Automatic Carbon-Dioxide for Endoscope	Surgical Innovations Ltd	HIF	Class II	1997-01-09
K954331	Pall Lea Filter (Lipid Emulsion Filter) (i.v. Filter)	Pall Biomedical Products Co.	FPB	Class II	1997-01-09
K965037	Cell Recovery System	Medical Device Technologies, Inc.	FDX	Class II	1997-01-08
K964547	Degania Silicone Indenti Loops	Degania Silicone, Inc.	DXC	Class II	1997-01-08
K964273	Dura-Board Armboard	Allen Medical Systems, Inc.	GDC	Class I	1997-01-08
K964218	Perfecta Plasma Spray Hip Stem	Wrightmedicaltechnologyinc	JDI	Class II	1997-01-08
K964122	Hp Star St and Arrhhythmia Software	Hewlett-Packard Co.	DSI	Class II	1997-01-08
K964080	Lori Hearing Aid Simulator	Lori Medical Laboratories, Inc.	KHL	Class II	1997-01-08
K964076	Laserscope Erbium; Yag Laser System and Accessories	Laserscope	GEX	Class II	1997-01-08
K963919	Lsi Videoscopic Display System	Lsi Solutions Inc.	GCJ	Class II	1997-01-08
K963760	Non-Shielded Surgical Trocar and Sleeve	Ethicon Endo-Surgery Inc	GCJ	Class II	1997-01-08
K961235	Sirius 180, 180L, 230, 230L	Micro-Mega Societe Anonyme	EFB	Class I	1997-01-08
K964012	Genie Processing and Review Workstation	GE Healthcare	KPS	Class II	1997-01-07
K963975	Versatec 310 Electrode	Versatec, Inc.	DRX	Class II	1997-01-07
K963620	9Th Wave Models 500 & 550 Low Air Loss Systems	9th Wave, Inc.	FNM	Class II	1997-01-07
K962978	Ccentermark Catheter Introducer Shealth with Protectiv 2000 Needle Safety System	Johnson & Johnson MEDICAL GmbH	DYB	Class II	1997-01-07
K962585	Unit-Matt 5000 Pressure Relief System	United Medical Equipment, Inc.	FNM	Class II	1997-01-07
K960995	CPR Bio-Barrier Facesheild	O-Two Systems Intl., Inc.	CBP	Class II	1997-01-07
K964284	Stainless Steel Greenfield Vena Cava Filter with 12F Introducer System	Boston Scientific Corporation	DTK	Class II	1997-01-06
K964192	Ardent Non Gamma-2 70	Ardent Production Development	EJJ	Class II	1997-01-06
K964103	Olympique Medical Support Hose and Stockings	Tournier-Bottu S.A.	DWL	Class II	1997-01-06
K964050	First Midcath Catheter	Becton Dickinson Vascular Access, Inc.	FOZ	Class II	1997-01-06
K964049	First Midcath Catheter with Dual Lumens	Becton Dickinson Vascular Access, Inc.	FOZ	Class II	1997-01-06
K964048	First Midcath Catheter Kit	Becton Dickinson Vascular Access, Inc.	FOZ	Class II	1997-01-06
K963672	Model 90022 Rolling Stand	Augustine Medical, Inc.	JOW	Class II	1997-01-06
K963595	Seragard Vascular Access Device	Cutting Edge Technologies, Inc.	FMI	Class II	1997-01-06
K962768	Cyto-Stat Trichrome Cd45-Fitc/cd4-Rdi/cd3-Pc5 Monoclonal Anitbody Reagent W/isotypic Control	Coulter Corp.	GKZ	Class II	1997-01-06
K962305	Cyto-Stat Trichrome Cd45-Fitc/cd8-Rd1/cd3-Pc5 Monoclonal Antibody Reagent Iwth Isotypic Control	Coulter Corp.	GKZ	Class II	1997-01-06
K954731	Oxylog 2	P.K. Morgan, Ltd.	BZL	Class II	1997-01-06
K964777	Tz	Gallini Intl., Inc.	KNW	Class II	1997-01-03
K964559	Portsmart Needle De-Access Enclosure	Jireh, Inc.	LJT	Class II	1997-01-03
K964326	Vision-Sciences Model S-V200 Color Mvideo Flexible Sigmoidoscope with Endosheath System	Cogentix Medical, Inc.	FAM	Class II	1997-01-03
K964165	Micro21 with Ndna	Triangle Biomedical Sciences, Inc.	DHN	Class II	1997-01-03
K963467	Roll Belts	DeRoyal Industries, Inc.	FMQ	Class I	1997-01-03
K962443	N95 Filtering Facepiece	Survivair, Inc.	FXX	Class II	1997-01-03
K961400	Rfa-300, Lda Utility	Scanditronix Medical AB	IYE	Class II	1997-01-03
K964809	Spetemp Ef	Ultradent Products Inc.	EMA	Class II	1997-01-02
K964798	Partial Ossicular Replacement Prosthesis	Anthony D. Prescott	ETB	Class II	1997-01-02
K964197	Impra Carboflo Eptfe Vascular Graft	Impra, Inc.	DSY	Class II	1997-01-02
K963403	Acuray Digital X-Ray	New Image Industries, Inc.	EHD	Class II	1997-01-02
K963255	Profix Plus Tibial Insert, Profix Ps Plus Tibial Insert, Profix P/s Tibial Insert	Smith & Nephew, Inc., Orthopaedic Div.	JWH	Class II	1997-01-02
K962662	Vingmed Sound Color Flow Mapping System	Diasonics, Inc.	IYO	Class II	1997-01-02
K962074	Vm Plus Peak Flowmeter	Clement Clarke Intl., Ltd.	BZH	Class II	1997-01-02
K964515	Acclaim Series Qd6000,qd6001,qd6002 and Series Qd3000,qd3001, Qd3002	M.C. Healthcare Products, Inc.	FNL	Class II	1996-12-31
K964411	Taki Acupuncture Needles	Lhasa Medical, Inc.	MQX	Class II	1996-12-31
K964145	Abradent Micro Abrasive Sandblaster Model Dv-1	Crystal Mark, Inc.	KOJ	Class II	1996-12-31
K964134	Trus<t>lift Porch Lift	Trus T Lift	ING	Class II	1996-12-31
K964127	Medi-Vac Flexi-Clear Suction Handle	Medtronic, Inc.	GCX	Class II	1996-12-31
K964070	Deknatel Dsp Pleur-Evac Autotransfusion Blood Recovery Bag	Deknatel, Inc.	CAC	Class II	1996-12-31
K964057	Incare Hot/ice System Shoulder Blanket	Hollister, Inc.	ILO	Class II	1996-12-31