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 1948 of 3531

510(k) clearances, page 1948 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964027	Stp System-Pva with Mercury	Sage Products LLC	LIO	Class I	1996-11-01
K963911	Alpco/mercodia Insulin Elisa	American Laboratory Products Company	CFP	Class I	1996-11-01
K963550	Rinoflow Micronized e.n..t. Wash Sytstem	Respironics, Inc.	KMA	Class I	1996-11-01
K963199	Heelbo Pelvic Restraint	Hollister, Inc.	FMQ	Class I	1996-11-01
K963099	Heelbo Pullover Poncho and Pullover Poncho with Pocket	Heelbo, Inc.	FMQ	Class I	1996-11-01
K963046	Endocam	Corin USA	GCJ	Class II	1996-11-01
K963042	Innosan Travelair S Portable Oxygen Concentrator, Code No. M407001853	Sim Italia S.r.l.	CAW	Class II	1996-11-01
K963035	Micro Spirometer	Micro Direct, Inc.	BZG	Class II	1996-11-01
K963034	Femtex Gentle Touch Tampons	First Quality Hygienic, Inc.	HEB	Class II	1996-11-01
K963025	Sleepnet Humidifier,(84200 Packaged)	SleepNet Corporation	BTT	Class II	1996-11-01
K962482	Scuba System	Gynecare, Inc.	HIH	Class II	1996-11-01
K962083	Karl Storz Remorgida Forceps	Karl Storz Endoscopy-America, Inc.	KNS	Class II	1996-11-01
K962081	Combilines Hemodialysis Blood Tubing Set	National Medical Care, Medical Products Div., Inc.	FJK	Class II	1996-11-01
K962028	Wellcolex E-Coli Oi57 Zc60	Murex Diagnostics, Inc.	GNA	Class I	1996-11-01
K961935	Sharplan Lasers, Inc. Silktouch CO2 Flash Scanner	Sharplan Lasers, Inc.	GEX	Class II	1996-11-01
K961836	Maxima Forte Hardshell Venous Reservoir	Medtronic, Inc.	DTN	Class II	1996-11-01
K961710	Aoc Medical System Model Phase II 25 Surgical Diode Laser System	Applied Optronics Corp.	GEX	Class II	1996-11-01
K961705	Aoc Medical System Model Phase II 50 Surgical Diode Laser System	Applied Optronics Corp.	GEX	Class II	1996-11-01
K961272	Nihon Kohden ECG-9320A Cardiofax and Accessories	Nihon Kohden America Inc	LOS		1996-11-01
K943824	Gaseous Oxygen Analyzer (Model S-3A) Modification	Ametek, Inc.	CCL	Class II	1996-11-01
K963766	3M Proplus System	3M Company	ELW	Class II	1996-10-31
K963527	Universal Econo-Strap, Qualcraft Universal Straps	Alimed, LLC	FMQ	Class I	1996-10-31
K963419	Morrison Medical Wrist Restraint	Morrison Medical Products	FMQ	Class I	1996-10-31
K963393	Mesh Vest Restraint with Sleeves Wrist/ankle Restraint	Depuy, Inc.	FMQ	Class I	1996-10-31
K963292	Cobas Integra Reagent Cassettes & Ancillary Reagents	Roche Diagnostic Systems, Inc.	CIC	Class II	1996-10-31
K963274	V-Link 3.2 for Windows	Koven Technology, Inc.	IYO	Class II	1996-10-31
K963233	Ez-Screen Profile	Editek, Inc.	LCM	Unclassified	1996-10-31
K963041	Heelbo Life Jacket with Crotch Support	Heelbo, Inc.	FMQ	Class I	1996-10-31
K962993	Cynosure Photoappeal CO2 Surgical Lasers	Cynosure, LLC	GEX	Class II	1996-10-31
K962764	Neuromag-122	Philips North America LLC	OLY	Class II	1996-10-31
K961784	Copalis One Immunoassay System/toxoplasma Gondii/rubella/cmv Total Antibody Assays	Sienna Biotech, Inc.	LQN	Class II	1996-10-31
K961645	Mrs-2D	Lexicor Medical Technology, Inc.	HCC	Class II	1996-10-31
K961621	Therapy Concepts Water Circulating Treatment System	Therapy Concepts, Inc.	ILO	Class II	1996-10-31
K961364	Automatic Tubing Clamp System (Atc)	Rocky Mountain Research, Inc.	KRL	Class II	1996-10-31
K961361	Asta-Cath	A+ Products	GBM	Class II	1996-10-31
K960590	Tri-Clean 110/Tri-Clean Plus Glove	Aladan Corp.	LYY	Class I	1996-10-31
K963833	Imx Free Triiodothyronine (Free T3)	Abbott Medical	CDP	Class II	1996-10-30
K963827	Axsym Free Triiodothyronine (Free T3)	Abbott Medical	CDP	Class II	1996-10-30
K963816	Levo Compact Lc	Levo USA	IPL	Class II	1996-10-30
K963666	Instant Cold Pack	Kick Ice, Inc.	IMD	Class I	1996-10-30
K963606	Visualine Combo V (Cocaine/thc) Test	Sun Biomedical Laboratories, Inc.	LDJ	Class II	1996-10-30
K963602	Bioderm Pvp Foam Wound Dressing	Bioderm, Inc.	KMF	Class I	1996-10-30
K963543	Sigma Diagnostics Cx -3 Calibration Standard, Level 2	Sigma Diagnostics, Inc.	JIX	Class II	1996-10-30
K963529	Verdict Barbiturates	Editek, Inc.	DIS	Class II	1996-10-30
K963516	Verdict Thc	Editek, Inc.	LDJ	Class II	1996-10-30
K963367	Rms K-Wire	Rms Div.	HTY	Class II	1996-10-30
K963218	Bantex Surgical Latex Gloves- Type 1 Natural Rubber Latex Surgicsl Gloves, Sterile	American Bantex Corp.	KGO	Class I	1996-10-30
K963188	Drain/slit Sponge (Non-Sterile and Sterile)	Codi International BV	EFQ	Unclassified	1996-10-30
K962988	Coulter Gen-S System	Coulter Corp.	GKL	Class II	1996-10-30
K962795	Cedia Dau Opiate 2K Assay	Boehringer Mannheim Corp.	DJG	Class II	1996-10-30