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 1962 of 3531

510(k) clearances, page 1962 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K961985	Elect Blood Glucose Monitorig System	Selfcare, Inc.	CGA	Class II	1996-09-05
K961969	Hitachi Stratis, Mrh-1500 Magnetic Resonance Diagnostic Devices Version 6 Operating System Software	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1996-09-05
K961628	Mini Flex Coil	W. L. Gore & Associates, Inc.	MOS	Class II	1996-09-05
K961594	Better-Venter	Circulatory Technology, Inc.	DWF	Class II	1996-09-05
K961525	Array Open Breast Coil (Model Obc-63 Pa)	Mri Devices Corp.	MOS	Class II	1996-09-05
K961261	Dynatron 525	Dynatronics Corp.	LIH	Class II	1996-09-05
K961105	Skin Dose Monitor	Mcmahon Medical	OWB	Class II	1996-09-05
K960860	Greiner Vacuette Blood Collection Tube E/edta K3	Greiner America, Inc.	JKA	Class II	1996-09-05
K960578	Elvis Hsv Gold	Ortho-Clinical Diagnostics, Inc.	GQN	Class II	1996-09-05
K955887	Newmed Abp-Lite	Newmed Inc	DXW	Class II	1996-09-05
K962618	Gyrex V-Ep	Elscint, Inc.	LNH	Class II	1996-09-04
K962595	Karl Storz Xenon 300 Light Source for Non-Flash Applications	Karl Storz Endoscopy-America, Inc.	FFS	Class II	1996-09-04
K962519	Emit 2000 Gentamicin Assay and Calibrators	Behring Diagnostics, Inc.	LCD	Class II	1996-09-04
K962375	Microvasive Balloon Gastrostomy Tube Kit	Boston Scientific Corporation	KNT	Class II	1996-09-04
K962177	Bard Taperseal Intra-Aortic Balloon Catheter & Introducer Kit	C.R. Bard Inc	DSP	Class II	1996-09-04
K961991	Acl 6000 System (Acl 6000)	Instrumentation Laboratory Co.	GKP	Class II	1996-09-04
K961597	Gated Mibi 3-D Ejection Fraction Processing	Trionix Research Laboratory, Inc.	KPS	Class II	1996-09-04
K961176	Omni Cold Gel Packs	Omni Therm, Inc.	IMD	Class I	1996-09-04
K961053	Seraquest Rubella Igg	Quest Intl., Inc.	LFX	Class II	1996-09-04
K960194	Myelotec Myeloscope	Myelotec, Inc.	HRX	Class II	1996-09-04
K955788	Imni Hot Packs	Omni Therm, Inc.	IMD	Class I	1996-09-04
K963093	Siremobil Compact	Siemens Medical Solutions USA, Inc.	OXO	Class II	1996-09-03
K962946	Ortho-One	Bisco, Inc.	DYH	Class II	1996-09-03
K962935	Unimed Coated Needle Electrode/coated Blade Electrode/coated Ball Electrode	Unimed Surgical Products, Inc.	GEI	Class II	1996-09-03
K962616	Synthes Dorsal Distal Radius Plate (Ddrp) System	Synthes (USA) Products LLC	HRS	Class II	1996-09-03
K962496	Soft Tissue Augmentation Tube (S.t.a.t.)	Tissue Technologies, Inc.	FTL	Class II	1996-09-03
K962439	Dermaplex Hydrogel Wound Dressing (2X2,4x4,4x8,6x10)	Richard Hamer Assoc., Inc.	MGQ	Unclassified	1996-09-03
K962401	Gore-Tex Dualmesh Plus Biomaterial with Holes	W. L. Gore & Associates, Inc.	FTL	Class II	1996-09-03
K962383	Pulpdent Resilute II	Pulpdent Corporation	EMA	Class II	1996-09-03
K962377	3D-Spine	Skill Technologies, Inc.	KQX	Class I	1996-09-03
K962315	Select Shoulder Cocr Humeral Stem Component	Intermedics Orthopedics	KWT	Class II	1996-09-03
K962242	Surescan	Clinicon Corp.	GEX	Class II	1996-09-03
K962192	Sunrise Curing Lamp	Sunrise Technologies, Inc.	EBF	Class II	1996-09-03
K961410	Durasil (Modification)	The S. F. Group, Inc.	MDA	Class I	1996-09-03
K960785	Lfs Lipogel Assay Kit	Zaxis, Inc.	JHO	Class I	1996-09-03
K950025	Self Propelled Robotic Wheel (Sprw)	Datatran, Inc.	ITI	Class II	1996-09-03
K963165	Elecsys Calcheck Hcg	Boehringer Mannheim Corp.	JJX	Class I	1996-08-30
K962885	Sealex Extra Root Canal Sealer	Baladent	KIF	Class II	1996-08-30
K962794	Etest for Aztreonam	Ab Biodisk	JWY	Class II	1996-08-30
K962758	Dsl 9100 Igf-II Irma	Diagnostic Systems Laboratories, Inc.	CFL	Class I	1996-08-30
K962672	Accusign Bzo-Rapid One-Step Benzodiazepine Assay	Princeton BioMeditech Corp.	JXM	Class II	1996-08-30
K962609	Gram Negative Identification Plus Card	Biomerieux Vitek, Inc.	LRH	Class I	1996-08-30
K962549	Vidas Creatine Kinase Mb Assay 30-421	Biomerieux Vitek, Inc.	JHX	Class II	1996-08-30
K962272	Synthes Mandible Distractor	Synthes (USA) Products LLC	MQN	Class II	1996-08-30
K962231	Cobas Core Immunochemistry System	Roche Diagnostic Systems, Inc.	JJE	Class I	1996-08-30
K962044	Valleylab Coated Electrodes	Medtronic, Inc.	GEI	Class II	1996-08-30
K962020	S-41 & S-41S Video Imaging System	Del Medical Systems Corp.	GCJ	Class II	1996-08-30
K961697	Opticon Female Urinary Incontinence Catheter for Continuous Drainage	Medical Device Intl., Inc.	EZL	Class II	1996-08-30
K960858	Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator	Greiner America, Inc.	JKA	Class II	1996-08-30
K960857	Greiner Vacuette Blood Collection Tube W/lithium Heparin & Gel Separator	Greiner America, Inc.	JKA	Class II	1996-08-30