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 1066 of 3531

510(k) clearances, page 1066 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K090750	Rt300-Sl, Model Fa100052; Rt300-Slsa, Model Fa104581	Restorative Therapies Inc.	GZI	Class II	2009-08-05
K082329	Viramed Biotech Ag Borrelia B31 Igm Virastripe	Viramed Biotech AG	LSR	Class II	2009-08-05
K092207	Restorelle Polypropylene Mesh	Mpathy Medical Devices, Ltd.	OTP	Class III	2009-08-04
K091062	Medos Hilite Infant Reservoir, Model Mvc 0730	Gish Biomedical, Inc.	DTN	Class II	2009-08-04
K090777	Ezc Medical, Llc Intubaidflex	Ezc Medical, LLC	BTR	Class II	2009-08-04
K091944	Modification to: Dss Stabilization System	Paradigm Spine GmbH	NQP	Class II	2009-08-03
K091768	Video Sciences Brs-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor & Accessories	Cogentix Medical, Inc.	EOQ	Class II	2009-08-03
K091659	Bard 3Dmax Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321, 011732	C.R. Bard Inc	FTL	Class II	2009-08-03
K091333	S-Test Ldl Cholesterol (Ldl), Model Rc0022	Alfa Wassermann	MRR	Class I	2009-08-03
K091319	Remstar Auto a-Flex	Respironics Inc., Sleep & Home Respiratory Group	BZD	Class II	2009-08-03
K091129	Quattro Lt	ResMed Corp	BZD	Class II	2009-08-03
K083707	Arthrex Dual Wave Arthroscopy Fluid Management Device	Arthrex GmbH	HRX	Class II	2009-08-03
K083302	Lifecare Electrodes	Everyway Medical Instruments Co., Ltd.	GXY	Class II	2009-08-03
K083097	Amsco V-Pro 1 Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2009-08-03
K091993	Rapid Programmer, Version 3.3.0	Advanced Neuromodulation Systems, Inc. (Ans Inc.)	GZB	Class II	2009-07-31
K091796	Softlase Pro, Ortholase and Hygienelase	Zap Lasers, LLC	GEX	Class II	2009-07-31
K091500	Modification To:fully Automatic Electronic Blood Pressure Monitor, Model Kd-556	Andon Health Co., Ltd	DXN	Class II	2009-07-31
K091494	Flexitime Flow	Kulzer GmbH	ELW	Class II	2009-07-31
K091491	Hero Vascular Access Device	Hemosphere, Inc.	DSY	Class II	2009-07-31
K091229	Glucomanager Data Management Software	Eps Bio Technology Corp.	NBW	Class II	2009-07-31
K091178	Mtp Disposable Equipment Covers, Karl Storz 15 Touch Screen	Mtp Medical Technical Promotion GmbH	MMP	Class II	2009-07-31
K090967	Bd Multitest 6-Color Tbnk Reagent, Model 644611	Becton, Dickinson and Company, BD Biosciences	GKZ	Class II	2009-07-31
K090949	Synthes (USA) 1.5Mm Headless Compression Screws	Synthes (USA) Products LLC	HWC	Class II	2009-07-31
K083913	Chesson Labs Liquid Bandage	Chesson Laboratory Associates, Inc.	KMF	Class I	2009-07-31
K083810	Pass Lp Spinal System	Medicrea Technologies	MNI	Class II	2009-07-31
K083410	Powder Free Latex Patient Examination Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim	WRP Asia Pacific Sdn Bhd	LZC	Class I	2009-07-31
K083408	Powder Free Nitrile Patient Examination Gloves, Tested for Use with Chemotherapy Drugs	WRP Asia Pacific Sdn Bhd	LZC	Class I	2009-07-31
K083222	Axis-Shield Liquid Stable (Ls) 2-Part Homocysteine Reagent, Model Fhrk100	Axis-Shield Diagnostics, Ltd.	LPS	Class II	2009-07-31
K070385	Ti-Tamed Spinal System	Ti-Tamed (Pty), Ltd.	NKB	Class II	2009-07-31
K092086	Amerigel Wound Dressing Plus 1/2 Oz. (15G Tube), Model A2025; 1 Oz. (30G Tube), Model A2026; 3 Oz (90G Tube),model A2027	Amerx Health Care Corp.	SEJ	Unclassified	2009-07-30
K092045	Fully Automatic Electronic Blood Pressure Monitor, Models Kd-738 and Kd-739	Andon Health Co., Ltd	DXN	Class II	2009-07-30
K092015	Peri-Loc Periarticular Locked Plating System	Smith & Nephew, Inc.	HRS	Class II	2009-07-30
K091997	Fully Automatic Electronic Blood Pressure Monitor, Model Kd-7962	Andon Health Co., Ltd	DXN	Class II	2009-07-30
K091988	Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076	Vertebral Technologies, Inc.	MAX	Class II	2009-07-30
K091966	Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040	Spectranetics Corp.	PNO	Class II	2009-07-30
K091961	Modified Concentric Microcatheter, Model 90047	Concentric Medical, Inc.	DQO	Class II	2009-07-30
K091719	Neosalus Lotion	Quinnova Pharmaceuticals	FRO	Unclassified	2009-07-30
K091693	Tds Zirconia Abutment for Nobel Biocare Branemark	Pou YU Biotechnology Co., Ltd.	NHA	Class II	2009-07-30
K091662	Powdered Vinyl Patient Examination Gloves	Zhangjiagang Fengyuan Plastic Products Co., Ltd.	LYZ	Class I	2009-07-30
K091563	Recruit Microcatheter	Reverse Medical Corporation	MMX	Class II	2009-07-30
K091422	Novapro Stretch Vinyl Examination Glove Powder Free (Yellow/white)	Novapro Co. Ltd.	LYZ	Class I	2009-07-30
K091392	Tds Titanium Abutment for Nobel Biocare Branemark	Pou YU Biotechnology Co., Ltd.	NHA	Class II	2009-07-30
K091390	Hdc Sterile Self Ligating Spider Screw, Model Sli,sl2	Hdc S.r.l.	OAT	Class II	2009-07-30
K091380	Cordcap	Centrix, Inc.	MVL	Unclassified	2009-07-30
K091236	Mantra Combo, Model Mecs 320	Mantra Intl. (Hk), Ltd.	GZJ	Class II	2009-07-30
K091190	Universal Clamp Stainless Steel System, Models Sna027-0-30060, Sna027-0-30063	Zimmer Spine, Inc.	JDQ	Class II	2009-07-30
K091013	Silver Pu Antibacterial Foam Dressing - Non Adherent and Island	Advanced Medical Solutions Limited	FRO	Unclassified	2009-07-30
K090954	Atlas Wound Matrix	Wrightmedicaltechnologyinc	KGN	Unclassified	2009-07-30
K090918	Nfocus Neuromedical Echo Distal Access Catheter	Nfocus Neuromedical, Inc.	DQY	Class II	2009-07-30
K090867	Airbloc Transseptal Introducer, 53 Cm, Model Fa001, Airblock Transseptal Introducer, 72 Cm ,Model Fa002	Ep Dynamics, Inc.	DYB	Class II	2009-07-30