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 1755 of 3531

510(k) clearances, page 1755 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990601	Bojrab Micro-Torp, Model 7014-5845	Gyrus Ent LLC	ETA	Class II	1999-03-31
K990516	Ethyl Alcohol Clinical Standard Solutions	EMD Millipore Corporation	DNN	Class II	1999-03-31
K990436	Ultimax Trochanteric Intramedullary Rod System	Biodynamic Technologies, Inc.	HSB	Class II	1999-03-31
K990424	Abbott Liquid Immunology Control Models 2E01-01/2E02-01/2E03-01	Bio-Rad	JJY	Class I	1999-03-31
K990354	Endosheath	Cogentix Medical, Inc.	EOB	Class II	1999-03-31
K990311	Vega Retic Automated Hematology Analyzer	Horiba Instruments Incorporated	GKZ	Class II	1999-03-31
K990264	Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (Rgp), Daily Wear Contact Lens	Metro Optics of Austin, Inc.	HQD	Class II	1999-03-31
K990251	Dgtx Flex Reagent Cartridge, Model Df36	Siemens Healthcare Diagnostics Inc.	LFM	Class II	1999-03-31
K990220	Modification of Gip/medi-Globe Ultrasound Needle System	Medi-Globe GmbH	FCG	Class II	1999-03-31
K990086	Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram	Integra LifeSciences Corporation	KGN	Unclassified	1999-03-31
K990868	Viewpoint Passive Tool Option	Philips North America LLC	HAW	Class II	1999-03-30
K990860	Viewpoint Microscope Option	Philips North America LLC	HAW	Class II	1999-03-30
K990855	Coopersurgical Infrared Coagulator for ENT	CooperSurgical, Inc.	KNS	Class II	1999-03-30
K990851	Indigo Laseroptic Treatment System	Indigo Medical, Inc.	GEX	Class II	1999-03-30
K990745	Modification to Synthes Universal Spinal System	Synthes GmbH	MNI	Class II	1999-03-30
K990708	Titanium Versalok	Wrightmedicaltechnologyinc	KWP	Class II	1999-03-30
K990703	Sporox II Sterilizing & Disinfecting Solution	Reckitt Benckiser LLC	MED	Class II	1999-03-30
K990608	Architect Cea Mastercheck, Model 6Co2-05	Bio-Rad	JJX	Class I	1999-03-30
K990278	Daum Neurocut Neurobiopsyneedle	Daum Corp.	KNW	Class II	1999-03-30
K990075	Lpulsa Syl-9000 Ophthalmic Yag Laser	Light-Med (USA), Inc.	HQF	Class II	1999-03-30
K990062	Saphlift	Genzyme Surgical Product (Genzyme Biosurgery)	MDM	Class I	1999-03-30
K982660	Orthopedic Perioperative Autotransfusion (Orthopat) System	Transfusion Technologies Corp.	CAC	Class II	1999-03-30
K990420	Laglove Brand Nitrile Examination Glove (Powder Free)	La Glove (M) Sdn. Bhd.	LZA	Class I	1999-03-29
K990415	Laglove Brand Nitrile Examination Gloves (Lightly Powdered)	La Glove (M) Sdn. Bhd.	LZA	Class I	1999-03-29
K990388	Tutoplus IV Administration Set	Myco Medical Supplies Inc	FPA	Class II	1999-03-29
K990299	Powder Free Blue Copolymer Nitrile Medical Examination Gloves	Shanghai Palomar Mountain Industries, Inc.	LZA	Class I	1999-03-29
K990267	Powdered Blue Nitrile Medical Examination Gloves	Shanghai Palomar Mountain Industries, Inc.	LZA	Class I	1999-03-29
K990210	Powdered Latex Examination Gloves with Protein Content Labeling Claim (100 Micrograms or Less of Total Water Extractabp	Mexpo Intl., Inc.	LYY	Class I	1999-03-29
K984641	Flexiscope Optomodul	Schoelly Fiberoptic, GmbH	EIA	Class I	1999-03-29
K984611	Drager Sola Series, Models 1000/700/500/300	Drager Medizintechnik GmbH	FSY	Class II	1999-03-29
K984039	Cranberry Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Lesss)	Cranberry (M) Sdn. Bhd.	LYY	Class I	1999-03-29
K983496	Resolution 45 (Spherical) and Ultra Gel (Toric) (Hioxifilcon B) Soft Daily Wear Contact Lens, )Clear & Blue Visibility T	Opti-Centre Laboratories	LPL	Class II	1999-03-29
K983225	Bausch & Lomb Renu Effervescent Enzymatic Contact Lens Cleaner	Bausch & Lomb Incorporated	LPN	Class II	1999-03-29
K982641	Advanced Nibp Module	Johnson & Johnson MEDICAL GmbH	DXN	Class II	1999-03-29
K990806	C1 Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	1999-03-26
K990786	Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/opi/coc/thc/pcp/bzo/bar/mtd/tca/amp, Biosign Doa10, Biosign Met/opi/	Princeton BioMeditech Corp.	LAG	Class II	1999-03-26
K990687	Hx-5/6-1 Endoscopic Clipping Device, Endoscopic Clips	Olympus Optical Co., Ltd.	PKL	Class II	1999-03-26
K990685	Trimethoprim/sulphamethoxazole (1/19)	Ab Biodisk	JWY	Class II	1999-03-26
K990657	Trifix Pedicle Spinal Screw Assembly	Corin USA	MNH	Class II	1999-03-26
K990556	Esophageal Intubation Detector	Wolfe Tory Medical, Inc.	BTR	Class II	1999-03-26
K990368	Duoderm Hydroactive Gel Wound Dressing	Convatec, A Bristol-Myers Squibb Co.	MGQ	Unclassified	1999-03-26
K990207	Gliadin Iga Elisa Test System	Zeus Scientific LLC	MST	Class II	1999-03-26
K990205	Digiscope Ophthalmic Camera	Eye Tel Imaging, Inc.	HKI	Class II	1999-03-26
K990204	Gliadin Igg Elisa Test System	Zeus Scientific LLC	MST	Class II	1999-03-26
K990050	Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042	Richard Wolf Medical Instruments Corp.	FGB	Class II	1999-03-26
K984591	Dornier Medilas H/2	Dornier Surgical Products, Inc.	GEX	Class II	1999-03-26
K982414	Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters	Gambro Healthcare	KDI	Class II	1999-03-26
K982278	Micrins Micro Anastomosis Clamp	Micrins Surgical, Inc.	DXC	Class II	1999-03-26
K990783	Vitros Immunodiagnostic Products Ca15-3 Range Verifiers, Ca125 II Range Verifiers, Psa Range Verifiers	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	1999-03-25
K990639	Acs Hi-Torque Cross It 100Xt, 200Xt and 300Xt Guide Wires with Hydrocoat Hydrophilic Coating.	Boston Scientific Corporation	DQX	Class II	1999-03-25