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 2139 of 3531

510(k) clearances, page 2139 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942960	Phosphate Qvet	Prisma Systems	CEO	Class I	1994-12-09
K941224	Lenzar Remote Acquisition System	Lenzar Electrooptics, Inc.	LMD	Class I	1994-12-09
K940660	Model 37-720 Dual Diode Dosimetry System	Victoreen, Inc.	IYE	Class II	1994-12-09
K935983	Microreader 4	Hyperion, Inc.	JJQ	Class I	1994-12-09
K935773	Exactech Porous Coated Posterior Stabilized Femoral Component	Exactech, Inc.	JWH	Class II	1994-12-09
K931318	3400 Infusion Pump	Graseby Medical, Ltd.	FRN	Class II	1994-12-09
K945717	Electrosurgical Endoscopic Cord	Boston Surgical Products, Inc.	GEI	Class II	1994-12-08
K945587	Candela Elliptical Spot Handpiece	Candela Corporation	GEX	Class II	1994-12-08
K945490	Latex Examination Glove	Masif Healthcare Products Sdn. Bhd.	LYY	Class I	1994-12-08
K945420	Chakoff Endoscopy	Stephen Chakoff, Inc.	FCW	Class II	1994-12-08
K945377	Trelex Natural(r) Mesh	Meadox Medicals, Div. Boston Scientific Corp.	FTL	Class II	1994-12-08
K945082	Cypress Medical Products Stethoscope	Cypress Medical Products LLC	LDE	Class I	1994-12-08
K944769	P.f.c. Apical Plug	Johnson & Johnson Professionals, Inc.	JDL	Class III	1994-12-08
K944751	Coulter Flow Set	Coulter Corp.	JPK	Class II	1994-12-08
K944659	Prodigy	Sybron Dental Specialties, Inc.	EBF	Class II	1994-12-08
K944642	Electrosurgical Cutting & Coagulation Device & Accessories	Boston Surgical Products, Inc.	GEI	Class II	1994-12-08
K944634	Electrosurgical Cutting & Coagulation Device & Accessories	Boston Surgical Products, Inc.	GEI	Class II	1994-12-08
K944578	Bipolar Cord	Boston Surgical Products, Inc.	GEI	Class II	1994-12-08
K944299	Karl Storz Insulated Biopsy Forceps	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-12-08
K944290	Catheters, Biliary Catheters, Urological	Boston Scientific Corporation	FFA	Class II	1994-12-08
K944067	Peanut Wand, Modification	Ideal Medical, Inc.	GCS	Class II	1994-12-08
K944024	Stimu-Tap	Wahl Clipper Corp	ISA	Class I	1994-12-08
K943858	Powder Free (Siliconized) Exam Gloves	Crocker Industrial Resources Sdn. Bhd.	LYY	Class I	1994-12-08
K943804	Bone Screw	Cohort Medical Products Group, Inc.	HWC	Class II	1994-12-08
K943552	Powder-Free Gloves	Healthcare Gloves Sdn Bhd	LYY	Class I	1994-12-08
K942874	Model #300To3500 Shoulder Coil	Medic, Inc.	LNH	Class II	1994-12-08
K942843	Cervex-Brush(r), Sterile, Spatula, Cervical, Cytology	Rovers Diagnostic Devices	HHT	Class II	1994-12-08
K942453	Guide Wire	Boston Scientific Corporation	DQX	Class II	1994-12-08
K942248	Miniaturized Finger Clip Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	1994-12-08
K942082	Model 6323 Oxygen Concentrator	Dynotec Corp.	CAW	Class II	1994-12-08
K941560	Immunocard H. Pylori	Meridian Diagnostics, Inc.	LYR	Class I	1994-12-08
K941128	Osteonics Series 7000 Basic Femoral Components	Osteonics Corp.	JWH	Class II	1994-12-08
K935923	Philips Ultrasound P800 Imaging System	Hewlett-Packard Co.	IYN	Class II	1994-12-08
K930731	Slip-Coat Stents	Cook Incorporated	FAD	Class II	1994-12-08
K945745	Esophageal Intubation Detector Adapter - (Eid-Adapter)	Wolfe Tory Medical, Inc.	BTR	Class II	1994-12-07
K945727	Catco Neonatal Palate Guard	Catco Medical, Inc.	BRW	Class I	1994-12-07
K945657	Disposable Heat and Mositure Exchanger and Hme/filter	Tec II Medical, Inc.	BYD	Class I	1994-12-07
K945637	R-Med Motorized Laparoscopic Handle	R-Med, Inc.	GCJ	Class II	1994-12-07
K945341	Multiple	Mi MI Progress Co., Ltd.	HQY	Class I	1994-12-07
K945337	Phenytoin Calibrators	Diagnostic Reagents, Inc.	DLJ	Class II	1994-12-07
K945322	Phosphorus Test (Phos) Item Number 65416	EMD Millipore Corporation	CEO	Class I	1994-12-07
K945282	Multiple	Mi MI Progress Co., Ltd.	HQY	Class I	1994-12-07
K944605	Cx Phencyclidine Reagent for Synschron Cx System	Beckman-Diagnostic Systems Group	LCM	Unclassified	1994-12-07
K944604	Cx Amphetamines Reagent for Synchron Cx Systems	Beckman-Diagnostic Systems Group	DKZ	Class II	1994-12-07
K944355	Nipro Branded Disposable Syringes, Needles	Nissho Corp.	FMF	Class II	1994-12-07
K944223	Accucon	Innovision, Inc.	HQD	Class II	1994-12-07
K944207	Topographic Modeling System 2 Tms-2	Computed Anatomy, Inc.	HLQ	Class I	1994-12-07
K944140	Comfit	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-12-07
K943987	Opx-Vx Feberoptic Intracranial Pressure Monitoring Catheter with Drainage	Innerspace Medical, Inc.	GWM	Class II	1994-12-07
K943802	Hp Back Pointer System	Medtec LLC	IWE	Class I	1994-12-07