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 1362 of 3531

510(k) clearances, page 1362 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042837	Liquichek Elevated Crp Control	Bio-Rad	JJX	Class I	2004-11-02
K042809	Cuffpatch	Organogenesis, Inc.	FTM	Class II	2004-11-02
K042496	Adept Ultralite 532 Laser	Adept Medical Concepts	GEX	Class II	2004-11-02
K042446	Quantify Control and Quantify Plus Controls	Bio-Rad Laboratories Inc.	JJW	Class I	2004-11-02
K042339	Neoplant Implant System	Neobiotech Co., Ltd.	DZE	Class II	2004-11-02
K040890	3M Tegaderm Silver	3M Company	FRO	Unclassified	2004-11-02
K040021	Shuntcheck (Prometheus 1)	Samuel Neff M.D.	JXG	Class II	2004-11-02
K042670	Futurabond Nr	Voco GmbH	KLE	Class II	2004-11-01
K042196	Savedent Blue	Denfotex Light Systems, Ltd.	EBZ	Class II	2004-11-01
K042134	Versatile 1 Wound Vacuum System	Blue Sky Medical Group Incorporated	OMP	Class II	2004-11-01
K042093	Vanguard M Series Unicondylar Tibial Bearings	Zimmer GmbH	HRY	Class II	2004-11-01
K042069	Invisio Irl Digital Rigid Laparoscope System	Acmi Corporation	GCJ	Class II	2004-11-01
K041088	Trifusion, Model 0609190/0659350	C.R. Bard Inc	LJS	Class II	2004-11-01
K040301	Gamcath High Flow Catheter, Ref: Gdhk 13Xx a	Gambro Renal Products	MPB	Class II	2004-11-01
K042903	Autospecs	Philips North America LLC	KPS	Class II	2004-10-29
K042839	C-Pet Plus Imaging System	Philips North America LLC	KPS	Class II	2004-10-29
K042793	Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)	Siemens Medi Cal Solutions, Inc.	OWB	Class II	2004-10-29
K042750	Qc-Beads	Bioscreen, Inc.	NRF	Class II	2004-10-29
K042724	Modification to Coulter Lh 500 Hematology Analyzer	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2004-10-29
K042720	On-Board Imager Device	Varian Medical Systems, Inc.	IYE	Class II	2004-10-29
K042695	Ncb Plating System	Zimmer GmbH	HRS	Class II	2004-10-29
K042598	Periarticular Locking Plates and Screws, 2357 and 2359 Series	Zimmer GmbH	HRS	Class II	2004-10-29
K042485	Tina-Quant Crp (Latex) Hs Test System (C-Reactive Protein (Latex) High Sensitive)	Roche Diagnostics GmbH	NQD	Class II	2004-10-29
K042480	Infant Whole Body Software Option for Qdr Densitometers	Hologic, Inc.	KGI	Class II	2004-10-29
K042460	Ti - Screw Anchor Sp	Arthrotek, Inc.	MBI	Class II	2004-10-29
K042448	Diazyme Homocysteine Enzymatic Assay Kit	General Atomics	JJX	Class I	2004-10-29
K042193	Diazyme Glycated Serum Protein Enzymatic Assay Kit	Diazyme Laboratories, Inc.	LCP	Class II	2004-10-29
K042191	Diazyme Potassium Enzymatic Assay Kit	Diazyme Laboratories, Inc.	MZV	Class II	2004-10-29
K042095	Mammotest	Fischer Imaging Corp.	IZH	Class II	2004-10-29
K041490	IV Administration Sets with Ultrablock UV-Resistant Tubing	B.Braun Medical, Inc.	FPA	Class II	2004-10-29
K041100	Nexgen Porous, Ha/tcp, Uncemented Femoral and Tibial Baseplate Components	Zimmer GmbH	MBH	Class II	2004-10-29
K041090	Hdl-Ex Seiken Assay Kit	Denka Seiken Co., Ltd.	LBS	Class I	2004-10-29
K040959	Mentor Genesis Penile Prosthesis	Mentor	FAE	Class II	2004-10-29
K042934	1Bd Soloshot IX Syringe	Becton Dickinson & Co	FMF	Class II	2004-10-28
K042832	Sienet Cosmos (Version V15a)	Siemens AG Medical Solutions	LLZ	Class II	2004-10-28
K042831	Atp (Auto Non-Contact Tonometer/pachymeter)	Reichert, Inc.	IYO	Class II	2004-10-28
K042810	Centurion Ses Epikeratome	Norwood Abbey, Ltd.	HNO	Class I	2004-10-28
K042407	Emit Caffeine Assay	Siemens Healthcare Diagnostics Inc.	KLS	Class II	2004-10-28
K042388	Radiant Medical Endocatheter Temperature Probe	Radiant Medical	DQY	Class II	2004-10-28
K042275	Vistakon (Senofilcon a) Soft Contact Lens	Johnson & Johnson Vision Care, Inc.	LPL	Class II	2004-10-28
K042006	Vitros Chemistry Products Dhdl Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products Performace	Ortho-Clinical Diagnostics, Inc.	LBS	Class I	2004-10-28
K041659	C-Boot	C-Boot, Ltd.	JOW	Class II	2004-10-28
K041478	Bd Logic Blood Glucose Monitor and Paradigm Link Blood Glucose Monitor	Becton Dickinson & Co	CGA	Class II	2004-10-28
K041271	Sterngold 3.25 Era Dental Implant System	Sterngold	DZE	Class II	2004-10-28
K040750	Bio-Chem Analyzer, Model 100	Clinical Analysis Corporation, Inc.	CEM	Class II	2004-10-28
K031753	Karats Multipurpose Solution	Alcon Laboratories	LPN	Class II	2004-10-28
K042833	Sonoline G20 Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	IYO	Class II	2004-10-27
K042673	Zodiac Polyaxial Spinal Fixation System	Alphatec/Nexmed	KWP	Class II	2004-10-27
K042355	Synthes (USA) Lcp Wrist Fusion Plates	Synthes (USA) Products LLC	HRS	Class II	2004-10-27
K042268	Ebi Cas Spine Spacer System	Ebi, LLC	MQP	Class II	2004-10-27