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 2403 of 3531

510(k) clearances, page 2403 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K913900	V*care Manual Resuscitator, Cat#vr-1000	Salter Labs	BTM	Class II	1992-01-07
K913531	Patient Examination Glovews	Pt. Sarana Indoprotex	LYY	Class I	1992-01-07
K913326	Dhd Metered Dose Inhaler (Mdi) Spacer	Dhd Diemolding Healthcare Div.	CAF	Class II	1992-01-07
K904939	Flexible and Rigid Ureterotome System	Olympus Corp.	EZO	Class II	1992-01-07
K915163	Protein S Eid Kit and Protein S Eid Bulk Plates	Biopool AB	GGP	Class II	1992-01-06
K915156	I-125 Seeds Code: 6702	Medi-Physics Inc. dba Nycomed Amersham Imaging	KXK	Class II	1992-01-06
K914910	Davol Laparoscopic Instruments (Gen Surg Reusable)	Davol, Inc.	GEI	Class II	1992-01-06
K914581	Heart Technology Wireclip	Heart Technology, Inc.	DQX	Class II	1992-01-06
K914514	1.9 French Lithotripter Electrode, Modification	Northgate Technologies Inc.	FFK	Class II	1992-01-06
K914484	Litespot(tm) Laser Indirect Ophthalmoscope	Hgm Medical Laser Systems, Inc.	HLI	Class II	1992-01-06
K914478	Nsn #6545-00-656-1093 Kit, First Aid	Cooperative Workshops, Inc.	LYY	Class I	1992-01-06
K914143	Kodak X-Omat 480 Ra Processor	Eastman Kodak Company	IXW	Class II	1992-01-06
K913418	Senographe Dmr/smr/dm	General Electric Co.	IZH	Class II	1992-01-06
K912509	Mossimo Optic Eyewear	Mossimo, Inc.	HQY	Class I	1992-01-06
K915083	Coamate(r) Antithrombin Chromogenic Assay	Kabi Pharmacia, Inc.	JBQ	Class II	1992-01-03
K914586	Grieshaber Three Function Manipulator	Grieshaber & Co.	EQH	Class I	1992-01-03
K914585	Grieshaber Two Function Manipulator	Grieshaber & Co.	EQH	Class I	1992-01-03
K914555	Workstation Femoral Intravascular Retrieval (Modi)	Med Institute, Inc.	DRE	Class II	1992-01-03
K914497	Biopsy Forceps	Surgitek Medical Engineering Corp.	FCL	Class I	1992-01-03
K914463	Abbott Quickstart Sgot, Item Number: 5A42	Em Diagnostic Systems, Inc.	CIT	Class II	1992-01-03
K914142	Hemo-Pulse 2000	Chrono Dynamics, Ltd.	IRP	Class II	1992-01-03
K913667	Antithrombin III Immunological Nl Test Kit	The Binding Site	JBQ	Class II	1992-01-03
K911061	Espe Ketac-Endo Aplicap	H.A. Opotow Consulting	EMA	Class II	1992-01-03
K915399	Qualicheck 4	Radiometer America, Inc	JJS	Class I	1992-01-02
K914438	Playtex Ultimates Unscented/scented Tampons	Playtex Family Products, Inc.	HIL	Class II	1992-01-02
K914436	Clinical Handmaster System or Chms	Exos Medical Products	LBB	Class II	1992-01-02
K913602	Ideas' Port	Ideal Medical, Inc.	FMF	Class II	1992-01-02
K913315	Bio-Rad Total Protein Test Kit	Bio-Rad	CEF	Class I	1992-01-02
K913114	Trim-Port(tm) Implant Access Syst Dual Titan Port	Gerard Medical Enterprises, Inc.	FMF	Class II	1992-01-02
K912358	Landmark Add-a-Lumen Catheter Kit	Menlo Care, Inc.	FOZ	Class II	1992-01-02
K911802	Pmi (Patient Matched Implants) Hip Femoral Comp	Zimmer GmbH	JDI	Class II	1992-01-02
K914913	Grice Foot Pedal Control/reddick Irri/aspir Syst	Ideal Medical, Inc.	GDJ	Class I	1991-12-31
K914903	Quickstart Urea Nitrogen	Em Diagnostic Systems, Inc.	CDN	Class II	1991-12-31
K914813	Therastim	Precision Electronics, Ltd.	GZJ	Class II	1991-12-31
K914500	Opti-Plast 5F Pta Catheters, Modification	Vas-Cath, Inc.	LIT	Class II	1991-12-31
K914425	Pyramid Sunglasses/reading Glasses	Pyramid	HQY	Class I	1991-12-31
K914413	Spectacle Frames	Mikado Ca.	HQZ	Class I	1991-12-31
K914407	Promoglass(tm) Sunglasses (Non-Prescription)	Promedex, Inc.	HQY	Class I	1991-12-31
K913919	Universal Terminal Cap, 3.2Mm	Telectronics Pacing Systems, Inc.	KFJ	Class III	1991-12-31
K913785	Coronet 100	Micro-Shev, Ltd.	GWJ	Class II	1991-12-31
K913560	Stopcock	Graham Medical Products	FMG	Class II	1991-12-31
K912813	Sirius	Pfizer Laser Systems	GEX	Class II	1991-12-31
K912639	Sonicaid Team	Oxford Medilog, Inc.	HGM	Class II	1991-12-31
K912257	Chem-Sleeve B	Haz-Med, Inc.	KME	Class I	1991-12-31
K910665	Model 556 Monitor W/24-Hr. Trend Recall/modified	GE Medical Systems Information Technologies, Inc.	DRT	Class II	1991-12-31
K905068	Pti Intra-Art (Tm) Pick-Up Wicks	Pioneering Technologies, Inc.	EFQ	Unclassified	1991-12-31
K915546	Ps Medical Ventriculostomy Kit	Pudenz-Schulte Medical Research Corp.	HBG	Class II	1991-12-30
K915461	Phonak 9000-Af Ite Hearing Instrument Series	Phonak, Inc.	ESD	Class I	1991-12-30
K915248	Lpg Casting Alloy	Aalba Dent, Inc.	EJH	Class II	1991-12-30
K915247	Npg III Casting Alloy	Aalba Dent, Inc.	EJH	Class II	1991-12-30