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 1971 of 3531

510(k) clearances, page 1971 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962295	Precision Qid Blood Glucose Test Strip	Medisense, Inc.	CGA	Class II	1996-07-26
K962189	Comfit Powder Free Green Examination Gloves (Hypoallergenic, Low Protein)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1996-07-26
K962188	Comfit Powder Free Blue Examination Gloves (Hypoallergenic, Low Protein)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1996-07-26
K962017	Hypodermic Jet Injection Apparatus	American Jet Injector Corp.	EGM	Class II	1996-07-26
K961970	Command 2 Micoelectric Surgical System	Stryker Corp.	HWE	Class I	1996-07-26
K961807	Certain Hct Level a & Level B/cvm Hct Levels 1,2,3, & 4	Ciba Corning Diagnostics Corp.	GLK	Class II	1996-07-26
K961793	Bi-Loc Bipolar Cup	Ortho Development Corp.	KWY	Class II	1996-07-26
K961748	Medlite/erbium Laser System	Continuum Biomedical, Inc.	GEX	Class II	1996-07-26
K961742	Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series System	Alm Surgical Equipment, Inc.	FQO	Class I	1996-07-26
K961704	Mti-Mp Transitional Implants and Modular Prosthetic System	Dentatus USA Ltd.	ELS	Class II	1996-07-26
K961639	Leksell Image Guidance Surgical System (Ligs)	Elekta Instrument AB	HAW	Class II	1996-07-26
K961287	Rocket Pleuraseal II Chest Drainage System	Rocket Medical	KDQ	Class II	1996-07-26
K960800	Cedia Red Blood Cell Folate (No Boil Reagent Pack)	Boehringer Mannheim Corp.	CGN	Class II	1996-07-26
K955844	Applicators for Varian Varisource Remote High Dose Rate Afterloader	Varian Assoc., Inc.	JAQ	Class II	1996-07-26
K955792	Wilo Series Secur, Automatic Trocar Set, Trocar, Conical, Triangular Ground, Safety W/out Lock, Set of Suction - Irriga0	Wilo Medizintechnik Lothar Wilberg GmbH	GEI	Class II	1996-07-26
K954968	Health Check Uri-Test Glucose in Urine Test	Tcpi, Inc.	JIL	Class II	1996-07-26
K954293	Patient Examination Glove (Powdered)	Medline Products Co., Ltd.	LYY	Class I	1996-07-26
K951976	Echo. Akho	Alliance Medical Corp.	IYO	Class II	1996-07-26
K962775	Sunglasses (Non-Prescription)	Canadd Trading Co.	HQY	Class I	1996-07-25
K962725	Soma	Soma International, Ltd.	HQY	Class I	1996-07-25
K962688	Montgomery Radiopaque Salivary Bypass Tube	Boston Medical Products, Inc.	KCF	Class I	1996-07-25
K962636	Sunglasses, Gaudi Sun Line	Gaudi SpA	HQY	Class I	1996-07-25
K962532	Rodenstock Slitlamp (Model 5000 & 4000)	Expertech Assoc., Inc.	HJO	Class II	1996-07-25
K962522	Model Sl-Yz5e	Pacific Ophthalmic Supply	HJO	Class II	1996-07-25
K962478	(Brand Name) Sunglass Frames	Custom Optical Frames, Inc.	HQY	Class I	1996-07-25
K962419	Cw-Disposable Acupuncture Needle	Acupuncture Supplies Import Co.	MQX	Class II	1996-07-25
K962382	Xiamen Chingsong Optical Industrial Co., Ltd.	Xiamen Chingsong Optical Industrial Co., Ltd.	HQY	Class I	1996-07-25
K962337	Elitys or Elitys-E	Trophy Radiologie	EHD	Class II	1996-07-25
K962298	Center Optical Glasses	Mirage Eyewear, Inc.	HQY	Class I	1996-07-25
K962265	Mlx Microtiter Plate Luminometer	Dynatech Laboratories, Inc.	JSE	Class I	1996-07-25
K962170	Siemens Vita 160 Series Pocket Hearing Instrument: Vita 162E,166m,168pp	Siemens Hearing Instruments, Inc.	ESD	Class I	1996-07-25
K962163	Misten Medical Misten Medical Surgical Drill	Misten Medical Corp.	ERL	Class II	1996-07-25
K962140	Ict-2000, Integrated C-Arm/table Multipurpose Radiographic/fluoroscopic Positioning System Model No. 6896.300	Continental X-Ray Corp.	JAA	Class II	1996-07-25
K962120	Tomograph Accessories	Steri-Oss, Inc.	EHD	Class II	1996-07-25
K961909	Ready-Set Punctal Plugs	Fci Ophthalmics, Inc.	LZU	Unclassified	1996-07-25
K961900	Tibial Tray Plug, a Product Line Addition to the Axiom Total Knee System	Wrightmedicaltechnologyinc	HRY	Class II	1996-07-25
K961876	Airis	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1996-07-25
K961820	Storz Dp4600 Anterior Intraocular Pressure Control Pack	Storz Instrument Co.	HQC	Class II	1996-07-25
K961757	Ecogel 100 Ultrasound Gel	Eco-Med Pharmaceuticals, Inc.	ITX	Class II	1996-07-25
K961753	Shared Vision(part Number Sv 0015)	Imagelabs, Inc.	LMD	Class I	1996-07-25
K961744	Tk40 - Tiltmaster	Mechanical Application Designs, Inc.	ITI	Class II	1996-07-25
K961675	Bg Patient Examination Gloves, Non-Sterile	Biografik (Malaysia) Sdn Bhd	LYY	Class I	1996-07-25
K961644	Miniox 3000 Oxygen Monitor	Minesafety Appliances Co.	CCL	Class II	1996-07-25
K961455	Medshield/aerochamber	Diemolding Corp.	CCQ	Class I	1996-07-25
K961454	Ammi Magni-Guard	American Medical Mfg., Inc.	LYU	Class I	1996-07-25
K961453	Kodak Mn-R 2000 Cassette	Eastman Kodak Company	IXA	Class II	1996-07-25
K961217	Bodily Fluid Disposal Kit	Transidyne General Corp.	FXX	Class II	1996-07-25
K961029	Kiltex Probe Cover	Kiltex Corp.	IYO	Class II	1996-07-25
K961007	Expert Spine Morphotietry Reference	Lunar Corp.	KGI	Class II	1996-07-25
K960833	Viotec S-4000-Cr Security Series Ultraviolet Germicidal Air Purification System	Uv Technologies, Inc.	FRA	Class II	1996-07-25