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 1778 of 3531

510(k) clearances, page 1778 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982140	Clinical Electronic Thermometer	Valeo Corp.	FLL	Class II	1998-12-08
K974845	Bta Stat Test Prescription Home Use	Bard Diagnostic Sciences,Inc.	MMW	Class II	1998-12-08
K974096	Crx Diamond Valve	Phoenix Biomedical Corp.	JXG	Class II	1998-12-08
K984011	Vitros Immunodiagnostic Products Cortisol Range Verifiers	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	1998-12-07
K983972	Immulite Troponin I, Model Lkti1 and Lkt15	Siemens Healthcare Diagnostics Inc.	MMI	Class II	1998-12-07
K983759	Abbott Architect Ferritin	Abbott Medical	DBF	Class II	1998-12-07
K983725	Omni Touch Nitrile Examination Glove, Powdered, Blue	Omnigrace, Ltd.	LZA	Class I	1998-12-07
K983723	Chlorinated, Polymer-Coated, Powder-Free Latex Examination Glove	Kossan Latex Industries (M) Sdn Bhd	LYY	Class I	1998-12-07
K983721	Polymer-Coated, Powder-Free, Latex Patient Examination Glove	Kossan Latex Industries (M) Sdn Bhd	LYY	Class I	1998-12-07
K983553	Anti-Tg Igg Elisa Test System	Columbia Bioscience, Inc.	JZO	Class II	1998-12-07
K983508	Osteo Compression Condyle Screw System	Osteonics Corp.	HWC	Class II	1998-12-07
K983345	Bayer Immuno 1 System, Upgraded for a Laboratory	Bayer Corp.	JJE	Class I	1998-12-07
K983263	Immulite Afp, Model Lkapi, Lkap5, Immulite 2000 Afp, Model L2kap2	Siemens Healthcare Diagnostics Inc.	LOJ	Class II	1998-12-07
K983219	Neoflow Option Model Numbers 8413563, 8411900	Drager, Inc.	CBK	Class II	1998-12-07
K983146	Arsoft	Alliance Rubber Products Sdn. Bhd.	LZA	Class I	1998-12-07
K983142	Ksea C-Mount Arthroscopes	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1998-12-07
K982728	Nellcor Puritan Bennett Uniprobe Adapter Cable, Up12a, Up12b, Up12c	Medtronic, Inc.	DQA	Class II	1998-12-07
K982433	Reaads Igm Anti-B2gp1 Test Kit	Corgenix, Inc.	MSV	Class II	1998-12-07
K982391	Reaads Igg Anti-B2gpi Test Kit	Corgenix, Inc.	MSV	Class II	1998-12-07
K981972	Green-or Dentin Desensitizer	Centrix, Inc.	LBH	Class II	1998-12-07
K981917	Powder Free (Chlorinated) Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)	Oon Corp. Resources	LYY	Class I	1998-12-07
K981746	Cell Robotics' Lasette	Cell Robotics, Inc.	GEX	Class II	1998-12-07
K981665	Silon Topomat Corneal Topography Image Enhancement Device	Bio-Medical Sciences, Inc.	MMQ	Class I	1998-12-07
K981054	Browne Ga Indicator for Cidex Products	Sybron Dental Specialties, Inc.	JOJ	Class II	1998-12-07
K974064	Micro X Residual Test Strips	Reprocessing Products Corp	MSY	Class II	1998-12-07
K984043	Quadrant Total Etch	Cavex Holland B.V.	EBF	Class II	1998-12-04
K984042	Quadrant Core Lc	Cavex Holland B.V.	EBF	Class II	1998-12-04
K984041	Quadrant Universal Lc	Cavex Holland B.V.	EBF	Class II	1998-12-04
K983947	Amerse 2	STERIS Corporation	LRJ	Class I	1998-12-04
K983942	Intramedullary Nail System, Locking Screw, Nail Cap	Smith & Nephew, Inc.	JDS	Class II	1998-12-04
K983917	Theratron Elite	Theratronics, Inc.	IWB	Class II	1998-12-04
K983881	Cobra External Fixator	Orthopaedic Innovations, Inc.	HRS	Class II	1998-12-04
K983825	Nitrile Latex Powder Free Examination Glove	Top Glove Sdn. Bhd.	LZA	Class I	1998-12-04
K983816	Nitrile Latex Powdered Examination Glove	Top Glove Sdn. Bhd.	LZA	Class I	1998-12-04
K983757	Syntec-Taichung Non-Sterile Knowles Pin, Models: for Hexagonal Collar: 2991-01/15,2992-01/15, for Square Collar:29992-01	Syntec Scientific Corp.	JDW	Class II	1998-12-04
K983685	Bone Band	Chapel and Assoc.	LYT	Class II	1998-12-04
K983645	Synthetic Powdered Vinyl Patient Examination Gloves	Shijiazhuang Great Eagle Plastic Products Co., Ltd.	LYZ	Class I	1998-12-04
K983641	Holland Femoral Nail System	Zimmer GmbH	HSB	Class II	1998-12-04
K983397	Stealthstation Treatment Guidance Plafform	Surgical Navigation Technologies, Inc.	HAW	Class II	1998-12-04
K983236	Bipolar HF Cable	Richard Wolf Medical Instruments Corp.	GEI	Class II	1998-12-04
K983226	Osteonics X Cemented Hip Stem Series	Osteonics Corp.	JDI	Class II	1998-12-04
K983215	Multipulse CO2 Laser	Aesculap-Meditec GmbH	GEX	Class II	1998-12-04
K983153	Natural-Knee II Posterior Stabilized (P.s.) Condylar Knee Tibial Inserts	Sulzer Orthopedics, Inc.	JWH	Class II	1998-12-04
K983129	Disposable Microstaar Injector (Model Msi-P1)	Staar Surgical AG	KYB	Class I	1998-12-04
K982995	Accutrax, Model Epf840	Korr Medical Technologies, Inc.	BZH	Class II	1998-12-04
K982885	Pre-Powdered Non-Sterile Synthetic Examination Glove	Shanghai Poseidon Plastic Products Co., Ltd.	LYZ	Class I	1998-12-04
K982812	G2 Total Hip System Femoral Stem (11/13 Taper)	Johnson & Johnson Professionals, Inc.	KWY	Class II	1998-12-04
K982614	Rusch Polyflex Stent Kit	Rusch Intl.	NYT	Class II	1998-12-04
K982275	Rapport V.t.d.	Owen Mumford USA, Inc.	LKY	Class II	1998-12-04
K982268	Ulnar Head Implant	Avanta Orthopaedics, Inc.	KXE	Class II	1998-12-04