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 1833 of 3531

510(k) clearances, page 1833 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K980613	Progold Electrocoping System	Micro Dental Laboratories	EJT	Class II	1998-03-09
K980597	Carrara Pdf, Carrara H, Carrara R	European Dental Imports, Inc.	EJT	Class II	1998-03-09
K980382	Non-Woven Compress	Convatec, A Division of E.R. Squibb & Sons	KMF	Class I	1998-03-09
K980298	Flowable Hybrid	Cosmedent, Inc.	EBD	Class II	1998-03-09
K980123	Carter-Thomason Needle-Point Suture Passer Instrument Set	Louisville Laboratories, Inc.	GCJ	Class II	1998-03-09
K980092	Smith & Nephew Dyonics Intelijet Reusable Cannulas	Smith & Nephew, Inc.	FRN	Class II	1998-03-09
K980022	Endopath Endoscopic Tissue Fastening System (Etfs)	Ethicon Endo-Surgery Inc	GCJ	Class II	1998-03-09
K974789	Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L	Lumenis Ltd	GEX	Class II	1998-03-09
K974759	Hydrox Saline Solution 0.9% Sodium Chloride 4 Oz. Cup 120 Ml 100 Ml Bottle	Hydrox Laboratories, Inc.	JOL	Class II	1998-03-09
K974758	Hydrox Sterile Water 4 Oz. Cup 120 Ml., Hydrox Sterile Water 100 Ml Bottle	Hydrox Laboratories, Inc.	JOL	Class II	1998-03-09
K974718	Persyst Prism	Persyst Development LLC	GWS	Class I	1998-03-09
K974631	Daum Neurobiopsy Needle	Daum Corp.	KNW	Class II	1998-03-09
K974597	Adc Compact (Agfa Diagnostic Center)	Bayer Corp., Agfa Div.	KPR	Class II	1998-03-09
K974587	H2o	Grass-Telefactor Product Group	OLV	Class II	1998-03-09
K974465	Synergy	Coltene /Whaledent AG	EBF	Class II	1998-03-09
K973916	Np Medical Capless Luer Activated Valve	NP Medical	FPA	Class II	1998-03-09
K980531	Aimstep Pregnancy	Germaine Laboratories, Inc.	JHI	Class II	1998-03-06
K980518	Osteomark	Ostex Intl., Inc.	JMM	Class I	1998-03-06
K980190	Acs 180 Br (Automated Chemiluminescence System)	Chiron Corp.	MOI	Class II	1998-03-06
K980056	Careside Analyzer	Exigent Diagnostics, Inc.	JJF	Class I	1998-03-06
K974889	Diamedix Is-RF Test System	Diamedix Corp.	DHR	Class II	1998-03-06
K974751	Tranquil Tri-Oe, Tranquil Tri-Coe, Tranquil Tri-Cic	General Hearing Instruments, Inc.	ESD	Class I	1998-03-06
K974585	If-727 Interferential Stimulator	Skylark Device Co., Ltd.	LIH	Class II	1998-03-06
K974576	Daum Biopsygun	Daum Corp.	KNW	Class II	1998-03-06
K974575	Daum Aspirationbiopsy Needle	Daum Corp.	KNW	Class II	1998-03-06
K974574	Daum Neuropuncture Needle	Daum Corp.	KNW	Class II	1998-03-06
K973993	Randox Creatinine	Randox Laboratories, Limited	CGX	Class II	1998-03-06
K972511	Amplatz Goose Neck Snare Kit/ Catheter	Microvena Corp.	DXE	Class II	1998-03-06
K980392	Psi-Tec Aspirator	Byron Medical	BTA	Class II	1998-03-05
K974757	Kaneda Anterior Scoliosis System Kass	Acromed Corp.	KWQ	Class II	1998-03-05
K974354	Mepiform Adherent Silicone Dressing for Scar Care	Sca Molnlycke	MDA	Class I	1998-03-05
K974291	Mitek Btb Absorbable (Pla) Cross Pin	Mitek Products	HTY	Class II	1998-03-05
K973883	Bio-Logic Ceegraph 128-Channel Recording System	Bio-Logic Systems Corp.	GWQ	Class II	1998-03-05
K973836	Synergy 6.35Mm Ss Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System	Cross Medical Products, Inc.	MNH	Class II	1998-03-05
K972185	20 Ml Normal Saline Topical Solution, 0.9% W/v Sodium Chloride	Steripak, Ltd.	FRO	Unclassified	1998-03-05
K964878	Esop S/c Femoral Stem	Fournitures Hospitalieres	MEH	Class II	1998-03-05
K980514	Chemtrak Platinum Comprehensive Liquid Assayed Chemistry and Tdm Control Level 1, Model Ap11001, Level 2, Model Ap22002	Medical Analysis Systems, Inc.	JJY	Class I	1998-03-04
K980461	Spectrum Designs Cleft Chin Implant	Spectrum Designs, Inc.	FWP	Class II	1998-03-04
K980374	Implant Site Dilators	BioHorizons Implant Systems Inc	DZE	Class II	1998-03-04
K980097	Flexigel-G Hydrogel Wound Dressing	Innovative Technologies, Ltd.	MGQ	Unclassified	1998-03-04
K980082	J-Tip Needless Injector	National Medical Products, Inc.	KZE	Class II	1998-03-04
K980075	Cybersonic	American Dentronics, Inc.	LCN	Class I	1998-03-04
K974755	Dyna Vue 3-D Imaging Product	Imd Systems, Inc.	LLZ	Class II	1998-03-04
K974700	Matrix Mt-Mx3	Medtec LLC	IYE	Class II	1998-03-04
K974625	Opti-Free Supraclens Daily Protein Remover	Alcon Laboratories	LPN	Class II	1998-03-04
K974624	Alcon Multi-Purpose Disinfecting Solution Id 90746	Alcon Laboratories	LPN	Class II	1998-03-04
K974614	Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1Tg 100-6250-0102	Elscint, Inc.	LNH	Class II	1998-03-04
K974558	Salvage/onocology Hip and Total Femur System	Zimmer GmbH	JDI	Class II	1998-03-04
K974546	Biosensor Holter Monitor System	Biosensor Corp.	DQK	Class II	1998-03-04
K974311	Vocom (Vocal Cord Medialization) Implant	Gyrus Ent LLC	KHJ	Class II	1998-03-04