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 2876 of 3529

510(k) clearances, page 2876 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863119	Cannulated Lag Screws	Downs Surgical, Ltd.	HTY	Class II	1986-09-03
K863083	Beta Medical Products Emr-301 Hydraulic Stretcher	Beta Medical Products Co.	FPO	Class II	1986-09-03
K863048	Opm Slit Lamp Model P-1 & Model P-3	Optek Medico Co., Ltd.	HJO	Class II	1986-09-03
K862811	Aqualux Lens Case	Safeway Products, Inc.	HPX	Unclassified	1986-09-03
K862764	Tina-Quant(r) Igg	Boehringer Mannheim Corp.	DEW	Class II	1986-09-03
K862721	Enzymatic Blood Glucose	U. S. Diagnostics, Inc.	CGA	Class II	1986-09-03
K862630	Mycoplasma Pneumoniae Antibody Latex Test System	Medical Diagnostic Technologies, Inc.	GSA	Class I	1986-09-03
K862547	Mechanical Inflation Device	American Edwards Laboratories	DXT	Class II	1986-09-03
K862477	Hoyer Digital Electronic Scale	Ted Hoyer & Co., Inc.	FRW	Class I	1986-09-03
K862338	Sensory 6	Brytech, Inc.	HPG	Class I	1986-09-03
K862301	Il System 810, Acl and the Reagent Sets	Instrumentation Laboratory Co.	GJA	Class II	1986-09-03
K862018	Micro Port	Intermedics/Infusaid, Inc.	LJT	Class II	1986-09-03
K863278	Surgi-Wipes	Dermacare Products, Inc.			1986-09-02
K863275	Martin Medical Pro-Spec Small Vaginal Speculum	Martin Medical	HIB	Class II	1986-09-02
K863274	Martin Medical Pro-Spec Medium Vaginal Speculum	Martin Medical	HIB	Class II	1986-09-02
K863214	Keisei Micro-Blades (Sterile and Non-Sterile)	Keisei Medical Industrial Co., Ltd.	GES	Class I	1986-09-02
K863213	Keisei Scalpel (Sterile and Non-Sterile)	Keisei Medical Industrial Co., Ltd.	GDX	Class I	1986-09-02
K863212	Keisei Handles for Surgical Blades	Keisei Medical Industrial Co., Ltd.	GDZ	Class I	1986-09-02
K863211	Keisei Surgical Blades (Sterile & Non-Sterile)	Keisei Medical Industrial Co., Ltd.	GES	Class I	1986-09-02
K862822	Rexillium N. B. F.	Jeneric Ind.	EJH	Class II	1986-09-02
K862689	2.5Mm Hex Driver/curve Passer/bone Punch/rasp	W. L. Gore & Associates, Inc.	HXX	Class I	1986-09-02
K862659	Concept Arthroscopy Rasp	Concept, Inc.	HTP	Class I	1986-09-02
K862616	Amber-Chest	Old Delft Corp. of America	KPR	Class II	1986-09-02
K862552	Acromed Ads Bone Nail	Buckman Co., Inc.	KTW	Class II	1986-09-02
K862550	Olbert Catheter System with Sidewinder Curve	Meadox Surgimed, Inc.	LIT	Class II	1986-09-02
K862535	Osteonics Shoulder Prosthesis	Osteonics Corp.	KWS	Class II	1986-09-02
K860749	Ha-2 Human Body Composition Analyzer	DJ Medical Instrument Corp. C/O Keller & Heckman	DSB	Class II	1986-09-02
K863250	Child's Rolls Powered Wheelchair	Invacare GmbH	ITI	Class II	1986-08-29
K863247	Axiom Trocar Thoracic Catheter	Axiom Medical, Inc.	GBS	Class I	1986-08-29
K863244	Amikacin (Fpia) Calibrator Kit	Windsor Laboratories, Inc.	DLJ	Class II	1986-08-29
K863201	New Use for Acuvac Suction Reservoir 400Cc	Allergan	GCY	Class I	1986-08-29
K863162	Vacu-Guard	Arbor Technologies, Inc.			1986-08-29
K863142	Thoracic Catheter (Chest Drainage Tube)	Sheridan Catheter Corp.	GBS	Class I	1986-08-29
K863094	Systemate (Tm) Alanine Transferase (Alt)	Em Diagnostic Systems, Inc.	CIT	Class II	1986-08-29
K863091	Bicord by Qmed	Qmed, Inc.	HAM	Class II	1986-08-29
K863090	Percu Guide I (Loop Type)	E-Z-EM, Inc	GDF	Class I	1986-08-29
K863005	Emds(tm) Total Protein Testpacks, #67663/95	Em Diagnostic Systems, Inc.	CEK	Class II	1986-08-29
K862926	Surgical Vitex	Jeneric Ind.	ELE	Class II	1986-08-29
K862905	Alp (Opt) Reagent	Sigma Diagnostics, Inc.	CJE	Class II	1986-08-29
K862876	New Super Poli-Grip Denture Adhesive Cream	Block Drug Company, Inc.	KOO	Class I	1986-08-29
K862845	Emds (Tm) Hdl Cholesterol Item No. 67679/95	Em Diagnostic Systems, Inc.	LBS	Class I	1986-08-29
K862819	Avl Model 984 Electrolyte Analyzer	Avl Scientific Corp.	JGS	Class II	1986-08-29
K862540	Left Ventricular Vent Valve Model No. Glv	Gish Biomedical, Inc.	DWD	Class II	1986-08-29
K862466	Schneider-Shiley Flushing Catheter	Shiley, Inc.	DQO	Class II	1986-08-29
K862407	Ciba Corning Magic Lite Tsh Immunoassay	Ciba Corning Diagnostics Corp.	JLW	Class II	1986-08-29
K862230	Warsaw Orthopedic Cancellous Bone Screw	Buckman Co., Inc.	HWC	Class II	1986-08-29
K862157	Omc Orthomet Cannulated Screw	Orthomet, Inc.			1986-08-29
K862119	Deseret Flo-Thru Injectate Temperature Sensor	Parke-Davis Co.	DYG	Class II	1986-08-29
K862005	Laserscope Omniplus Photosurgical System/co2 Laser	Laserscope	EWG	Class II	1986-08-29
K861708	Solid State Detector Computerized Tomographic	General Electric Co.	JAK	Class II	1986-08-29