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 2106 of 3531

510(k) clearances, page 2106 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K950219	Endolap Insufflator Tubing Set	Endolap, Inc.	HIF	Class II	1995-03-23
K950213	The Stern Root Anchor System	Sterngold/Implamed	ELR	Class I	1995-03-23
K950131	1.0Mm 1.8Mmo.d. Polyurethane Detached Model	Therex Corp.	LJT	Class II	1995-03-23
K950123	Sceptor System Panels	Becton Dickinson Microbiology Systems	JWY	Class II	1995-03-23
K950045	Kls-Martin Mandibular Fracture/reconstruction System	Karl Leibinger GmbH U. Co. KG	JEY	Class II	1995-03-23
K946334	Galen	Medimage, Inc.	KPS	Class II	1995-03-23
K945887	Precision Q I D Blood Glucose Test Strips	Medisense, Inc.	CGA	Class II	1995-03-23
K945885	Patient Examination Gloves	Hartalega Sdn Bhd	LYY	Class I	1995-03-23
K945870	R&d Part Nos. 5490, 5541, 5358, 5497	R & D Batteries, Inc.	FCO	Class I	1995-03-23
K945778	Phased Array Shoulder Coil, Quadrature Shoulder Coil	Medical Advances, Inc.	LNH	Class II	1995-03-23
K945740	Infant Flow System	Hamilton Medical AG	BZO	Class I	1995-03-23
K945619	Athena Hfx	Fischer Imaging Corp.	IZH	Class II	1995-03-23
K945537	T-Guard	Med et AL Development	LQX	Class I	1995-03-23
K945227	Ocide Hospital Cleaner-Disinfectant	Clariant Corporation	LRJ	Class I	1995-03-23
K944728	Bioresource Technology Liquichemtrol-Normal Liquid Heman Protein Electrophoresis Control	Bioresource Technology	JJY	Class I	1995-03-23
K944389	R&d Batteries Part Nos. 5111, 5112, 5065, 5153	R & D Batteries, Inc.	FCO	Class I	1995-03-23
K944388	R&d Batteries Part Nos. 5116, 5124, 5099, 5100	R & D Batteries, Inc.	FCO	Class I	1995-03-23
K944348	R&d Batteries, Inc. Part No. 5128, 5053, 5007	R & D Batteries, Inc.	FCO	Class I	1995-03-23
K944293	Sabratek Sabsil Sets	Sabratek Corp.	FPA	Class II	1995-03-23
K944195	Quickpro Blood Glucose Testing System	Medisense, Inc.	CGA	Class II	1995-03-23
K943977	Smart Anesthesia Multi-Gas (Sam) Module	Marquette Electronics, Inc.	CCK	Class II	1995-03-23
K943919	9.5 Fr Sensation Dl Intra-Aortic Ballon Catheter	Boston Scientific Corporation	DSP	Class II	1995-03-23
K943767	Immulite C-Peptide	Siemens Healthcare Diagnostics Inc.	JKD	Class I	1995-03-23
K943691	Imx Folate	Abbott Mfg., Inc.	CGN	Class II	1995-03-23
K940503	Mouth-to-Mask Resuscitator	Mtm Health Products, Ltd.	CBP	Class II	1995-03-23
K936110	Aspire	Dura Pharmaceuticals, Inc.	BZH	Class II	1995-03-23
K935235	Endoscopy System for Facial Plastic Surgery	Smith & Nephew Richards, Inc.	GCM	Class II	1995-03-23
K951082	Chakoff Endoscopy, Rigid Endoscope	Stephen Chakoff, Inc.	GCJ	Class II	1995-03-22
K951080	Sunglasses	Taiwan Georgia Corp.	HQY	Class I	1995-03-22
K951054	Xcel Slit Lamp	Leica, Inc.	HJO	Class II	1995-03-22
K950930	Trache-Tite	The Varner Group, Inc.	CBH	Class I	1995-03-22
K950928	Ultimates Silk Glide Tampons	Playtime Products, Inc.	HIL	Class II	1995-03-22
K950922	Champ International Corp.	Champ International Corp.	HQY	Class I	1995-03-22
K950822	Solopak Pharmaceuticals Inc. Sterile Empty Vial	Solopak Laboratories, Inc.	LDH		1995-03-22
K950796	Halogen Diagnostic Set Bx a - 12345	Neitz Instruments Company, Ltd.	HLJ	Class II	1995-03-22
K950790	Streak Retinoscope Rx-2	Neitz Instruments Company, Ltd.	HKL	Class II	1995-03-22
K950766	Sigma 8000 and Sigma 8002	Sigma Intl. General Medical Apparatus, Inc.	FRN	Class II	1995-03-22
K950553	Coldcide-2	Metrex Research	LRJ	Class I	1995-03-22
K950516	Coldcide-10	Metrex Research	LRJ	Class I	1995-03-22
K950324	Multi-Wash	Multi-Wash Medical, Ltd.	LRJ	Class I	1995-03-22
K946343	Intec Extended Eye Shield with Mask	Intec Industries, Inc.	FXX	Class II	1995-03-22
K946267	Gore-Tex Sam Facial Implant	W. L. Gore & Associates, Inc.	FWP	Class II	1995-03-22
K946227	Storz Premiere(r) Microsurgical System	Storz Instrument Co.	HQC	Class II	1995-03-22
K946226	Custom Ocular Prosthesis	Frank Tanaka, Ocularist, Inc.	HQH	Class I	1995-03-22
K946016	Ivalon Ophthalmic Sponge	Ivalon	HOZ	Class II	1995-03-22
K945973	Fms Arthroscopy Cannula	Future Medical Systems, Inc.	HRX	Class II	1995-03-22
K945889	Karl Storz Plastic Surgery Accessories	Karl Storz Endoscopy-America, Inc.	GCM	Class II	1995-03-22
K945658	Interwoven(tm) Reusable Surgical Gown	Baxter Healthcare Corporation	FYA	Class II	1995-03-22
K945004	2, 3 & 4 Bandadge Compress	Certified Safety Mfg Inc	EFQ	Unclassified	1995-03-22
K945002	1X6yd, 2X6yd, 4X6yd Roll Bandage	Certified Safety Mfg Inc	EFQ	Unclassified	1995-03-22