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 1848 of 3531

510(k) clearances, page 1848 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K971570	Epxpress System (Timberwolf Revision) /000391	Quinton Electrophysiology Corp.	DRR	Class II	1997-12-29
K974425	Biosign Hcg-One Step Pregnancy Test, Accusign Hcg-One Step Pregnancy Test, Lifesign Hcg-One Step Pregnancy Test	Princeton BioMeditech Corp.	DHA	Class II	1997-12-24
K974262	Syscos Idc - G, Idc, Bsc, Idc - G	Scantibodies Laboratory Inc.	MJX	Class I	1997-12-24
K974191	Evergreen Non-Sterile Powdered Latex Examination Glove	Yty Industry (Manjung) Sdn. Bhd.	LYY	Class I	1997-12-24
K974159	Osom Hcg-Urine Test Model 101	Wyntek Diagnostics, Inc.	JHI	Class II	1997-12-24
K974110	Immage Immunochemistry System Antithrombin III (At3) Reagent	Beckman Instruments, Inc.	JBQ	Class II	1997-12-24
K973761	Micro-Strip for Opiate Metabolites	Microdiagnostics, Inc.	DJG	Class II	1997-12-24
K973730	Durasil I and Durasil II	Hanson Medical, Inc.	MIB	Class II	1997-12-24
K973729	Powerflex Pec Implant	Hanson Medical, Inc.	MIC	Class II	1997-12-24
K973714	Versys Hip System Beaded Hip Prosthesis	Zimmer GmbH	LPH	Class II	1997-12-24
K973706	Dura-Guard-Dural Repair Patch	Bio-Vascular, Inc.	GXQ	Class II	1997-12-24
K973683	Omega 21 System	Ebi Electro Biology	MNH	Class II	1997-12-24
K971339	Insyte, Insyte-W, Insyte Autoguard Catheters	Becton Dickinson Vascular Access, Inc.	FOZ	Class II	1997-12-24
K974306	Sangui Biotech, Inc. Intact-Pth (Parathyroid Hormone) Elisa	Sangui Biotech, Inc.	CEW	Class II	1997-12-23
K974054	Distal Centralizer, Exeter II Hip System	Howmedica Corp.	JDI	Class II	1997-12-23
K974048	Incare Pelvic Floor Therapy System with Desktop Computer	Hollister, Inc.	KPI	Class II	1997-12-23
K973951	Levo Compact-Easy Lce	Levo USA	IPL	Class II	1997-12-23
K973807	Duoderm Hydroactive Paste	Convatec, A Bristol-Myers Squibb Co.	FRO	Unclassified	1997-12-23
K973767	Harmonic Imaging with Contrast	Acuson Corp.	IYO	Class II	1997-12-23
K973719	Medlite Q-Switched Nd:yag Laser, Medlite IV Q-Switched Nd:yag Laser	Continuum Biomedical, Inc.	GEX	Class II	1997-12-23
K973689	Duoderm Hydroactive Dressing	ConvaTec Limited	FRO	Unclassified	1997-12-23
K973688	Duoderm Control Gel Formula Border Dressing	ConvaTec Limited	FRO	Unclassified	1997-12-23
K973644	Flostat Vascular Lab	Biomedix Wai	JAF	Class II	1997-12-23
K973638	N.i.t., Inc. Needle Guiding Template	Avid N.I.T., Inc.	IWJ	Class I	1997-12-23
K973631	Lorad M-III Elite (M-III E)	Lorad Corp.	IZH	Class II	1997-12-23
K972480	3I Bioresorbable Fixation Tack	ZimVie US Corp LLC	DZL	Class II	1997-12-23
K971637	Compound Sulphonamides Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1997-12-23
K963969	Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options : 25, 20, 15 & 10 Watts) Indigo Fib	Indigo Medical, Inc.	GEX	Class II	1997-12-23
K963817	Levo Mobil Lcm	Levo USA	IPL	Class II	1997-12-23
K974551	Sealite Sciences, Inc. Aqualite Free T, Assay	Sealite Sciences, Inc.	CEC	Class II	1997-12-22
K974516	Endolap Resectoscope Cutting Loop Electrode	Endolap, Inc.	FAS	Class II	1997-12-22
K974515	Endolap Resectoscope Roller Electrode	Endolap, Inc.	FAS	Class II	1997-12-22
K974423	Ultra-Vision Mammography Detail, Ultra-Vision Mammography Fast Detail	Sterling Diagnostic Imaging, Inc.	EAM	Class I	1997-12-22
K974240	Lightline-M	Wuestec Medical, Inc.	IZX	Class II	1997-12-22
K974198	Taky-Spike Plus	Clinico	LHI	Class II	1997-12-22
K974068	Pfr95 Particulate Filter Respirator and Surgical Mask Regular Size, Pfr95 Particulate Filter Respirator and Surgical	Tecnol Medical Products, Inc.	MSH	Class II	1997-12-22
K974036	Pathway Vaginal/rectal Perineometer Probe	The Prometheus Group	HIR	Class II	1997-12-22
K974032	Rocket Mucus Sampler Syringe, Sterile, Rocket Mucus Sampler Syringe, Clinically Aspirator	A & A Medical, Inc.	HFC	Class II	1997-12-22
K973988	Rdi Homogeneous Hdl Cholesterol Test	Reference Diagnostics, Inc.	LBS	Class I	1997-12-22
K973959	Olicon Imaging Systems, Inc. 02-Workstation And/or Pacsview Software	Olicon Imaging Systems, Inc.	LMD	Class I	1997-12-22
K973954	Imagen Respiratory Screen	Dako Diagnostics, Ltd.	GNW	Class I	1997-12-22
K973908	Auklet CT Scanner, Tsx-003A	Toshiba America Medical Systems, In.C	JAK	Class II	1997-12-22
K973686	Endocare Cryocare Cryosurgical System	Varian Medical Systems, Inc.	GEH	Class II	1997-12-22
K973632	Duoderm Cgf Control Gel Formula Dressing	Convatec, A Division of E.R. Squibb & Sons	FRO	Unclassified	1997-12-22
K973513	Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal,sinfony Magic Modifiers, Sinfony Opaquer	Espe GmbH & Co. KG.	EBF	Class II	1997-12-22
K972914	Syvek Patch	Marine Polymer Technologies, Inc.	KGX	Class I	1997-12-22
K972555	Catheter Tunneler	Gerard Medical, Inc.	LJS	Class II	1997-12-22
K972406	Adenovirus Antigen Detection Elisa Test System	Immunoprobe, Inc.	GOD	Class I	1997-12-22
K971582	Nipro Coreless Needle/coreless Needle Set	Nipro Medical Corporation	LJT	Class II	1997-12-22
K971360	Syntex	Shinemound Enterprise, Inc.	LYZ	Class I	1997-12-22