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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2955 of 3529

510(k) clearances, page 2955 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852404	Lasersafe Eye Shields	Lasersafe, Inc.	HOY	Class I	1985-10-04
K852293	Bard-Parker Biliary Balloon Catheter	BD Becton Dickinson Vacutainer Systems Preanalytic	FGE	Class II	1985-10-04
K850909	Rhoda-Lux Lens Blanks	Optatint, Inc.	HPX	Unclassified	1985-10-04
K853853	Technicon Chem 1 Sys Analytes Magnesium Ggt, Uric	Technicon Instruments Corp.	JGJ	Class I	1985-10-03
K853269	Pregna/test	Modern Diagnostics, Inc.	LCX	Class II	1985-10-03
K853224	Phase II B-12/Folate Kit	Medical & Scientific Designs, Inc.	CDD	Class II	1985-10-03
K851822	Beta Scan Trends Meter	Orange Medical Instruments, Inc.	CGA	Class II	1985-10-03
K853753	Diamentor Patient X-Ray Exposure Indicator 07302	Victoreen, Inc.	KPR	Class II	1985-10-02
K853717	Allegro Tm Hs-Tsh Immunoassay System	Nichols Institute Diagnostics	JLW	Class II	1985-10-02
K853715	Para Con Tm	Para Scientific Co.	LKS	Class I	1985-10-02
K851517	Circa Med Single-Channel-Ambulatory Cardiac Monito	Circadian, Inc.	DSI	Class II	1985-10-02
K853835	Emit Qst Carbamazepine Assay	Syva Co.	KLT	Class II	1985-10-01
K853748	Ventrescreen Hcg Urine	Vxr, Inc.	JHI	Class II	1985-10-01
K853692	Sun Tanning Bed Model Ec-3Rf	Mottek Intl. Corp.	FTC	Class II	1985-10-01
K853679	Sunjet Models 240/280	Sunjet Manufacturer, Inc.	FTC	Class II	1985-10-01
K853587	Uvatan Indus. Uvatan 900C, 900B/800 & 600C	Uvatan Industries, Ltd.	FTC	Class II	1985-10-01
K853545	Flourescent T12 Uva Tanning Lamp	Light Sources, Inc.	FTC	Class II	1985-10-01
K853502	Various Fome-Cuf Tracheal Tubes W/sideport Airway	Bivona Medical Technologies	BTR	Class II	1985-10-01
K853411	Model 486-03 Poly Flex Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-10-01
K853391	Multipurpose Immunochemistry Sys-La-2000	Eiken Chemical Co., Ltd.	JJE	Class I	1985-10-01
K853345	31St. Centruy Medical Corp Time Buyer 428905 US Pe	31st. Centruy Medical Corp.	BWC	Class II	1985-10-01
K853258	Beta-Hcg Microtiter Pregnancy Test	Modern Diagnostics, Inc.	JHI	Class II	1985-10-01
K853171	International Model Sc Semicanal in the Ear Hear a	Int'L Hearing Aids, Inc.	ESD	Class I	1985-10-01
K852708	Implant Elect Lead, Mod 030-405 Using Polyu 90 a	Telectronics, Inc.	DTB	Class III	1985-10-01
K852405	Lasersafe Personnel and Patient Shields	Lasersafe, Inc.	CAI	Class I	1985-10-01
K852391	Edc/titan Geliso-Dot Total Ldh Isoenzyme Procedure	Helena Laboratories, Corp.	CFH	Class II	1985-10-01
K844776	Effner-Saling Laryngoscope for New-Born	Medical Instruments and Lamps	CCW	Class I	1985-10-01
K843821	Solco Basle Intraoperative Autottrnsfus	Solco Basle, Inc.	CAC	Class II	1985-10-01
K853887	Liqui-Sera Chem. Multiple Calibrators	Biodiagnostic Intl	JIT	Class II	1985-09-30
K853868	Albumin Sr Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	CIX	Class II	1985-09-30
K853826	Glucose Hexokinase for Continuous Flow Instruments	Catachem, Inc.	CFR	Class II	1985-09-30
K853825	Uric Acid(uricase) for Continuous Flow Instruments	Catachem, Inc.	KNK	Class I	1985-09-30
K853822	Amoena Breast Forms	MEDLINE INDUSTRIES, LP - Northfield	GBI	Class I	1985-09-30
K853489	Dextra Precision Power System	Chattanooga Group, Inc.	HWE	Class I	1985-09-30
K853453	Bio Automed Sys Chemistry Analyzer Auto-Loader	Bio Automed Systems, Inc.	JJQ	Class I	1985-09-30
K853438	H-H Hunter Active Tendon Implant	Holter-Hausner Intl.	HXA	Class II	1985-09-30
K852946	Sera Aris Pheno Reag Strip, Test Mod Cal & Clt	Miles Laboratories, Inc.	DLZ	Class II	1985-09-30
K852938	Tuf Track Model Tt83 Cubicle Track & Iv83 Intr Trk	Northern Customfab, Inc.	KPE	Class II	1985-09-30
K852807	Bio Medicus Bio Pump Model Bp-50	Bio Medicus, Inc.	KFM	Class II	1985-09-30
K852780	Bcd Plus Blood Cardioplegia Sys(hereaf Refer Dev)	Shiley, Inc.	DTR	Class II	1985-09-30
K852698	Bio Medicus Bio Pump Model Bp-80	Bio Medicus, Inc.	KFM	Class II	1985-09-30
K852694	Portalase 200 Carbon Surgical Laser System	Minnesota Laser Corp.	HHR	Class II	1985-09-30
K852651	Thera-Tronic Therapeutic Treatment Table	Rwm Co.	INQ	Class I	1985-09-30
K852538	Lkb 4057 Ultrospec II E	Lkb Instruments, Inc.	JJQ	Class I	1985-09-30
K852450	Lode Coagulometer Model Lc-6	Lode Corp.	JPA	Class II	1985-09-30
K852411	Mr 650 Microplate Reader(cat. No. 011-973-0500)	Dynatech Laboratories, Inc.	JJQ	Class I	1985-09-30
K852166	Thermo Shortwave Diathermy	Zimmer Elektromedizin GmbH	IMJ	Class II	1985-09-30
K853498	Perfect 10	North American Alloys, Inc.	EJH	Class II	1985-09-27
K853407	Intra Vaginal Transducer	Advanced Technology Laboratories, Inc.	HEM	Class II	1985-09-27
K853320	Frequency Response Analyzer Computer Sys Cci-10	Rastronics USA, Inc.	ETW	Class II	1985-09-27