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 1618 of 3531

510(k) clearances, page 1618 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K002696	Whittlestone Breastpump	Whittlestone, Inc.	HGX	Class II	2001-03-21
K002507	Two-Lumen Central Venous Access Kit with Hemostasis Valve/side Port	Arrow Intl., Inc.	DYB	Class II	2001-03-21
K010649	Exhale Doppler System	Broncus Technologies, Inc.	IYN	Class II	2001-03-20
K010642	Pleurx Pleural Catheter and Drainage Kits	Denver Biomedicals, Inc.	DWM	Class II	2001-03-20
K010640	Siemens Medical Information Bus (Mib II) Protocol Converter	Siemens Medical Solutions USA, Inc.	DRQ	Class II	2001-03-20
K010608	Modification to Lap Top Ventilator (Ltv)	Pulmonetic Systems, Inc.	CBK	Class II	2001-03-20
K010560	Portrait Femoral Component	Zimmer GmbH	LZO	Class II	2001-03-20
K010498	Wristwatch Blood Pressure Monitor A46	Rossmax Internationl, Ltd.	DXN	Class II	2001-03-20
K010482	Echoflow Portable Doppler Blood Flow Measurement System; Model Pef-1	Echocath, Inc.	JOP	Class II	2001-03-20
K010310	Modification to Trident All Poly Cup	Howmedica Osteonics Corp	JDI	Class II	2001-03-20
K010031	Nanoduct Neonatal Sweat Analysis System	ELITechGroup Inc	KTB	Class II	2001-03-20
K003923	Apex Modular Zirconia Femoral Head	VQ Orthocare	LZO	Class II	2001-03-20
K003352	Escreen System	Escreen, Inc.	LAF	Class II	2001-03-20
K003271	Modification to Iti Dental Implant System	Straumann USA, LLC	DZE	Class II	2001-03-20
K003185	Fs Activator III	Activator Methods International Ltd.	LXM	Unclassified	2001-03-20
K001581	Lactosorb 5.0 Mm Washer	Zimmer GmbH	HWC	Class II	2001-03-20
K001535	Zenith Plate System, Anterior Spinal Instrumentation	Ortho Tec, LLC	KWP	Class II	2001-03-20
K001412	Pm 1800 Conserving Device	Precision Medical, Inc.	NFB	Class II	2001-03-20
K010589	Microwavae Delivery System #Mw2000	Mw Medical, Inc.	MWY	Class II	2001-03-19
K010535	Trifix Spinal Fixation System	Endius, Inc.	MNH	Class II	2001-03-19
K010087	Xltek Real Patient Evoked Potential Headbox, Model Ep-16-Rp	Excel Tech., Ltd.	GWF	Class II	2001-03-19
K010052	Respironics Bilichek Non-Invasive-100-0800-20; Bilirubin Analyzer	Respironics, Inc.	MQM	Class I	2001-03-19
K010019	Sterile Subdermal Needle Electrodes	Nicolet Biomedical, Inc.	GXZ	Class II	2001-03-19
K003984	Super Revo Suture Anchor	Linvatec Corporation	MAI	Class II	2001-03-19
K003979	Medtrade Products Silicon Scar Management Pad	Medtrade Products Ltd.	MDA	Class I	2001-03-19
K003976	Baumer Muller Hip Prosthesis	Baumer S.A.	JDI	Class II	2001-03-19
K003975	Baumer Cemented Hip Prosthesis	Baumer S.A.	JDI	Class II	2001-03-19
K003910	Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (Cr) Articular Surface Components	Zimmer GmbH	JWH	Class II	2001-03-19
K003846	Accu-Chek Inform Meter	Roche Diagnostics GmbH	LFR	Class II	2001-03-19
K003747	C1-Inhibitor Microtiter Assay Device	Baxter Healthcare Corporation	DBA	Class II	2001-03-19
K003584	Neolynx Screening Application Manager	Micromass, Inc.	JNB	Class II	2001-03-19
K002665	Wristwatch Bpm Blood Pressure Monitor, Model Kp-6120	K-Jump Health Co., Ltd.	DXN	Class II	2001-03-19
K010224	Npac Multi-Use Thermometer, Model Td400	Norm Pacific Automation Corp.	FLL	Class II	2001-03-18
K010217	4 Port, 4 Way Stopcock	George Loo, MD	FMG	Class II	2001-03-18
K010609	Accusonic, Model as-260	Metron Medical Australia, Pty, Ltd.	IMI	Class II	2001-03-16
K010606	Safari	Ranger All Season Corp.	INI	Class II	2001-03-16
K010445	Precise Nitinol Stent Transhepatic Billary System	Cordis US Corp.	FGE	Class II	2001-03-16
K010409	Cbc-Sf	R & D Systems, Inc.	JPK	Class II	2001-03-16
K010298	Mn-4 Coarse Manipulator	Narishige Co., Ltd.	MQJ	Class II	2001-03-16
K010287	Scimedx Phase II Pr3 Igg Antibody Eia	Scimedx Corp.	MOB	Class II	2001-03-16
K010266	Triage B-Type Natriuretic Peptide (Bnp) Test, Catalog #98000	Biosite Incorporated	NBC	Class II	2001-03-16
K010223	Biocurve Soft (Methafilcon a) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Lathe-Cut)	American Contact Lens, Inc.	LPL	Class II	2001-03-16
K010218	Vistakon (Hefilcon C) Contact Lenses	Johnson & Johnson Vision Care, Inc.	LPL	Class II	2001-03-16
K010206	Dimension Enzymatic Carbonate (Eco2) Flex Method, Catalog Df137	Siemens Healthcare Diagnostics Inc.	KHS	Class II	2001-03-16
K010084	Real Patient Real Patient 128 Channel EEG Headbox, Model Ex-Nw-128-Rp	Excel Tech., Ltd.	GWQ	Class II	2001-03-16
K004014	Md 30 Compact	General Project S.r.l.	GEX	Class II	2001-03-16
K003995	Speculite/orallite	Trylon Corp.	EAZ	Class I	2001-03-16
K003965	MRI Safe Instruments	Aesculap Inc	GEA	Class I	2001-03-16
K003953	Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model Lf001	Ethicon Endo-Surgery Inc	GEX	Class II	2001-03-16
K003952	Indigo Laseroptic Treatment System	Ethicon Endo-Surgery Inc	GEX	Class II	2001-03-16