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 1500 of 3531

510(k) clearances, page 1500 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022931	Hyaluronidase Solution	FUJIFILM Biosciences Inc.	MQL	Class II	2002-11-04
K022751	Reprocessed Used Disposable Hot and Cold Biopsy Forceps	Medical Device Services	KGE	Class II	2002-11-04
K022047	Phlebotest 2000	Osborn Medical Corporation	JOM	Class II	2002-11-04
K022007	Liberty 5000 Breast Coil with Disposable Biopsy Plates	GE Healthcare Coils	MOS	Class II	2002-11-04
K021732	Dhf 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; Dhr 0.6 Hemoconcentrator: Dideco Pediatric/small Adult	Dideco S.p.A.	KDI	Class II	2002-11-04
K021576	Mercury Medical Statco2 End Tidal CO2 Detector, Model 10-55370	Mercury Medical	CCK	Class II	2002-11-04
K021467	Autocon II 400 Electrosurgical Generator	Karl Storz Endoscopy-America, Inc.	GEI	Class II	2002-11-04
K023538	Timex Accucurve Talking 30 Second Thermomter	Medport, Inc.	FLL	Class II	2002-11-01
K023457	Ultrasound Scanner, Type 1101	BK Medical ApS	IYO	Class II	2002-11-01
K023312	Control Plasma P	Siemens Healthcare Diagnostics Inc.	GGC	Class II	2002-11-01
K023309	Control Plasma N	Siemens Healthcare Diagnostics Inc.	GIZ	Class II	2002-11-01
K023198	Ceranum 90	Sb Lucius, Inc.	EJT	Class II	2002-11-01
K023196	Lucius 76	Sb Lucius, Inc.	EJT	Class II	2002-11-01
K022962	Wiener Lab. Bilirrubina Total Aa	Wiener Laboratories Saic	CIG	Class II	2002-11-01
K022843	Gayheart Corneal Excision Device	Stephens Instruments, Inc	HRH	Class I	2002-11-01
K022842	Stephens Disposable Hooks	Stephens Instruments, Inc	HNQ	Class I	2002-11-01
K022840	Stephens Disposable Scissors	Stephens Instruments, Inc	HNF	Class I	2002-11-01
K022836	Stephens Disposable Speculum	Stephens Instruments, Inc	HNC	Class I	2002-11-01
K022835	Stephens Disposable Forceps	Stephens Instruments, Inc	HNR	Class I	2002-11-01
K022681	Azog, Inc. Hcg One-Step Urine Pregnancy Test (Device or Cassette)	Azog, Inc.	DHA	Class II	2002-11-01
K022680	Azog, Inc. Hcg One-Step Urine Pregnancy Test Strip (Dipstick)	Azog, Inc.	DHA	Class II	2002-11-01
K022597	K-Fix	New Deal, S.A.	HTY	Class II	2002-11-01
K022594	Playtex Breast Pump	Playtex Products, Inc.	HGX	Class II	2002-11-01
K022593	Thomas Medical Electrodes	Thomas Medical, Inc.	HGI	Class II	2002-11-01
K022021	Vital Scientific Aptt, Aptt & Quikcoag Aptt	VitalScientific	GFO	Class II	2002-11-01
K022012	Synthes Low Profile Neuro System	Synthes (USA) Products LLC	JEY	Class II	2002-11-01
K021551	Stimulan - Calcium Sulfate Bone Void Filler Kit	Biocomposites, Ltd.	MQV	Class II	2002-11-01
K020886	Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett, Goodknight 420S Model M-113903-US	Tyco Healthcare Nancy	BZD	Class II	2002-11-01
K020540	Regenecare Wound Gel	MPM Medical	SEJ	Unclassified	2002-11-01
K011005	Pure Water Solutions Central Water System for Hemodialysis	Pure Water Solutions, Inc.	FIP	Class II	2002-11-01
K023495	Welch Allyn Vitals Software Developers Kit (Sdk)	Welch Allyn Inc	DXN	Class II	2002-10-31
K023488	Osstaple, Craniofacial	Biomedical Enterprises, Inc.	JEY	Class II	2002-10-31
K023486	Osstaple, Maxillofacial	Biomedical Enterprises, Inc.	JEY	Class II	2002-10-31
K023447	Modification to Ultimum Ev Hemostasis Introducer (22F)	Abbott Medical	DYB	Class II	2002-10-31
K023307	Mas Diabetes Control - Lyophilized Assayed Diabetes Control	Medical Analysis Systems, Inc.	JJX	Class I	2002-10-31
K023273	Bd Phoenix Automated Microbiology System - Gentamicin 0.25 - 16 Ug/ml	Becton Dickinson & Co	LON	Class II	2002-10-31
K022663	Keradec	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-10-31
K022638	Neurorecovery Ventricular Catheter & Main Valve Assembly Kit	Neurorecovery, Inc.	GWM	Class II	2002-10-31
K022583	Flash 1	Emed, Inc.	GEX	Class II	2002-10-31
K022570	Medcomp Repair Kit, Model Aspcrpk	Medcomp	NFK	Class II	2002-10-31
K021056	Permacol	Tissue Science Laboratories, PLC	FTM	Class II	2002-10-31
K020750	Digital Electrical Muscle Stimulator, Model Ev-807 Digital Ems	Everyway Medical Instruments Co., Ltd.	IPF	Class II	2002-10-31
K020749	Digital Transcutaneous Electrical Nerve Stimulator, Model Ev-803 Digital TENS	Everyway Medical Instruments Co., Ltd.	GZJ	Class II	2002-10-31
K020689	Sherlock Mycobacteria Identification System	Midi, Inc.	NJO	Class I	2002-10-31
K023441	Philips Multidiagnost Eleva	Philips North America LLC	IZI	Class II	2002-10-30
K023440	Philips Digital Imaging Option Release 1	Philips North America LLC	LLZ	Class II	2002-10-30
K023079	New Outline	Anaxdent GmbH	EBG	Class II	2002-10-30
K022599	Newdeal K Wire	New Deal, S.A.	HTY	Class II	2002-10-30
K022536	\Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector	Fresenius Medical Care	KOC	Class II	2002-10-30
K022060	Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories	Lumenis Ltd	GEX	Class II	2002-10-30