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 2244 of 3531

510(k) clearances, page 2244 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K930810	Tandem-R Ostase Immunoradiometric Assay	Hybritech, Inc.	CIN	Class II	1994-01-11
K922997	Via 1-01 Infusion Pump/blood Chem. Syst. -- Mod.	Via Medical Corp.	LZF	Class II	1994-01-11
K935060	Brennen Medical Sterile Saline Solution	Brennen Medical, Inc.	KMF	Class I	1994-01-10
K934751	Active Androstanediol Glucuronide	Diagnostic Systems Laboratories, Inc.	CIZ	Class I	1994-01-10
K934727	Replacement Parts for Cpi 6888 Lead Tunneler	Cardiac Pacemakers, Inc.	DWS	Class I	1994-01-10
K934427	Pilling Laparoscopic Instrumentation	Pilling Co.	GEI	Class II	1994-01-10
K933817	Royl-Derm Wound Hydrogel Sterile Unit Dose	Renaissance Medical, Inc.	MGQ	Unclassified	1994-01-10
K933642	R & D Batteries, Inc. Part # 5003, 5198, 5253	R & D Batteries, Inc.	FLL	Class II	1994-01-10
K933366	i.v. Link	Deville Laboratories, Inc.	FPO	Class II	1994-01-10
K933007	Slase 210 & Slase 210 Plus Holmium Laser Systems	Sunrise Technologies, Inc.	GEX	Class II	1994-01-10
K932973	Royl-Derm Wound Hydrogel Dressing	Renaissance Medical, Inc.	MGQ	Unclassified	1994-01-10
K932926	Immulite Estradiol	Siemens Healthcare Diagnostics Inc.	CHP	Class I	1994-01-10
K932347	Compact Mask	Vital Signs, Inc.	KGB	Class I	1994-01-10
K931936	Gianturco-Helfrich Hernis Mesh	Cook Inc.	FTL	Class II	1994-01-10
K931550	Ez Administration Set	Y	FPA	Class II	1994-01-10
K931548	Inamed Development Aspiration Tip	Inamed Development Co.	GCX	Class II	1994-01-10
K924930	Evita	Drager, Inc.	CBK	Class II	1994-01-10
K923504	Cholesterol Enzymatic Endpoint	Randox Laboratories, Limited	CHH	Class I	1994-01-10
K922652	Ace Basic Dental Implant Pack I	Ace Surgical Supply Co., Inc.	EIA	Class I	1994-01-10
K922651	Ace Dental Implant Kit	Ace Surgical Supply Co., Inc.	EIA	Class I	1994-01-10
K922650	Ace Dental Implant Custom Surgical Pack	Ace Surgical Supply Co., Inc.	EIA	Class I	1994-01-10
K922649	Ace Basic Dental Implant Pack II	Ace Surgical Supply Co., Inc.	EIA	Class I	1994-01-10
K934942	Patient Examination Glove	P.T. Surya Milani Plastic Utama	LYY	Class I	1994-01-07
K934813	Comfit Blue Powder Free Examination Glove	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-01-07
K934812	Comfit Green Powder Free Examination Glove	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-01-07
K934675	Metal Ureteral Basket Stone Dislodger	Annex Medical, Inc.	FFL	Class II	1994-01-07
K934598	Grasping Forceps or Retrieval Forceps	Annex Medical, Inc.	FGO	Class II	1994-01-07
K934560	Wizard Pediatric Wheelchair	R82 Inc.	IOR	Class I	1994-01-07
K934546	Powder-Free Latex Examination Glove	Powercrest (M) Sdn. Bhd.	LYY	Class I	1994-01-07
K934418	Basic Tilt Chair ( Btc )	Labac Systems, Inc.	IOR	Class I	1994-01-07
K934411	Meadox Surgimed Olbert Catheter System Noprofile	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1994-01-07
K934356	Wilson-Cook Gi Aspiration Needle	Wilson-Cook Medical Inc.	FCG	Class II	1994-01-07
K934345	Powder Free Latex Examination Gloves	Vas Latex Co., Ltd.	LYY	Class I	1994-01-07
K934289	Mayfield Radiolucent Skull Clamp	Ohio Medical Instrument Co., Inc.	HBL	Class II	1994-01-07
K934133	Patient Examination Gloves (Powder Free Gloves)	Supergrade Healthcare Products Sdn. Bhd.	LYY	Class I	1994-01-07
K934092	Camera, Surgical and Accessories	Envision Medical Corp.	FWB	Class I	1994-01-07
K934052	Alpine Reusable Leg Bags	Sierra Laboratories, Inc.	FAQ	Class I	1994-01-07
K933670	Biopsy Punch, Surgical	Byron Medical	EME	Class I	1994-01-07
K933622	Flexion Distraction Table	Spinalight Inc	INQ	Class I	1994-01-07
K933621	Hilo Table	Spinalight Inc	INQ	Class I	1994-01-07
K933505	Bosworth Copalioner	Harry J. Bosworth Co.	LBH	Class II	1994-01-07
K932916	Galvanic Generator Model Imf4150/a	BioMedical Life Systems Inc.	IPF	Class II	1994-01-07
K932739	Fast Start Neuromuscular Stimulator	Madeoutback Co., Ltd.	IPF	Class II	1994-01-07
K932637	Subcutaneous Infusion Set	Douglas Medical Products, Inc	FPA	Class II	1994-01-07
K932513	Labeling for Myo/wire II Sternotomy Sutures	Alto Development Corp	GAO	Class II	1994-01-07
K932509	Strato Medical Infuse-a-Port/snap-Lock Macroprort	Strato Medical Corp.	LJT	Class II	1994-01-07
K932493	Surgical Curette	Whitney Products, Inc.	FZS	Class I	1994-01-07
K932346	Aesculap Manual Endoscopic Instruments	Aesculap Inc	GCJ	Class II	1994-01-07
K932307	3M Maxi-Driver II Dbattery Powered System	3M Company	KIJ	Class I	1994-01-07
K932271	Magnetic Reson Diag Device Magnetom Project 016	Siemens Medical Solutions USA, Inc.	LNH	Class II	1994-01-07