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 1814 of 3531

510(k) clearances, page 1814 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K980971	Bodystat Dualscan 2005	Bodystat Ltd	MNW	Class II	1998-06-11
K980899	Jin Acupuncture Needles, Models St, Gl, Si, Pt, and Id	Kenshin Trading Corp.	MQX	Class II	1998-06-11
K980659	Dryalysate Concentrate	Advanced Renal Technologies, Inc.	KPO	Class II	1998-06-11
K971214	Kilowin	Cadwell Laboratories, Inc.	GWE	Class II	1998-06-11
K964153	Rossmax Automatic Wristwatch Blood Pressure Monitor, Model Rm-4000	Rossmax International Ltd.	DXN	Class II	1998-06-11
K981590	Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con	Bio-Rad	DIF	Class I	1998-06-10
K981495	Immulite Ck-Mb, Catalog # Lkcp1 (100 Tests), Lkcp5 (500 Tests)	Siemens Healthcare Diagnostics Inc.	JHS	Class II	1998-06-10
K981477	Medical Biopsy Automatic Cutting Needle	Medical Biopsy, Inc.	KNW	Class II	1998-06-10
K981422	Tc Series	Get A Life-Give A Living Plus Kids Project, Inc.	IOR	Class I	1998-06-10
K981421	Tc Series (Recliner)	Get A Life-Give A Living Plus Kids Project, Inc.	IOR	Class I	1998-06-10
K981420	Tc Series (Wide)	Get A Life-Give A Living Plus Kids Project, Inc.	IOR	Class I	1998-06-10
K981419	Tc Series (Tilt Recliner)	Get A Life-Give A Living Plus Kids Project, Inc.	IOR	Class I	1998-06-10
K981418	Tc Series (Transport)	Get A Life-Give A Living Plus Kids Project, Inc.	IOR	Class I	1998-06-10
K981387	Evanesce Scar Management System	Medical Scientific, Inc.	MDA	Class I	1998-06-10
K981377	Ace T4 Reagent T4 Calibrators	Schiapparelli Biosystems, Inc.	KLI	Class II	1998-06-10
K981375	Ace T Uptake Reagent Tu Calibrators	Schiapparelli Biosystems, Inc.	KHQ	Class II	1998-06-10
K981283	Rogachefsky Distal Radius Plates	Howmedica Corp.	HRS	Class II	1998-06-10
K980960	In-Check Inspiratory Flowmeter	Clement Clarke Intl., Ltd.	BZH	Class II	1998-06-10
K980957	Kaplan-Simpson Infusasleeve II	Localmed, Inc.	QEY	Class II	1998-06-10
K980785	Sterile, Powderfree Latex Examination Glove	London Intl., LLC	LYY	Class I	1998-06-10
K980121	Aesculap Spine System Additional Components	Aesculap Inc	KWP	Class II	1998-06-10
K980047	Uriscan S-300 Semi-Automated Urine Chemistry Analyzer	Yeongdong Pharmaceutical Corp.	KQO	Class I	1998-06-10
K973812	Arthrex Puddu Osteotomy System	Arthrex GmbH	HRS	Class II	1998-06-10
K973454	Ad-Tech's Spinal Electrode	AD-Tech Medical Instrument Corp.	GZL	Class II	1998-06-10
K970668	The Amplantz Goose Neck Microsnare	Microvena Corp.	DQY	Class II	1998-06-10
K981743	Olympus Au400 Clinical Chemistry Analyzer	OLYMPUS Corporation of the Americas	CKB	Class II	1998-06-09
K981517	Cefdinir, 5 Ug, Sensi-Disc	Becton Dickinson Microbiology Systems	JTN	Class II	1998-06-09
K981147	Clear (Tm) Lice Egg Remover System	Care Technologies, Inc.	LJL	Class I	1998-06-09
K981137	Etest Cefotaxime	Ab Biodisk	JWY	Class II	1998-06-09
K981136	Etest Fosfomycin	Ab Biodisk	JWY	Class II	1998-06-09
K981135	Etest Benzylpenicillin	Ab Biodisk	JWY	Class II	1998-06-09
K981109	Quitetip	Paradigm Medical Industries, Inc.	HQC	Class II	1998-06-09
K980983	The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery	Biomedics	JEY	Class II	1998-06-09
K980968	Lone Star Impression Systems	Lone Star Technologies	ELW	Class II	1998-06-09
K980870	Rusch Silicone Foley Catheter	Rusch, Inc.	EZL	Class II	1998-06-09
K980653	Perflex Stainless Steel Stent and Delivery System	Cordis US Corp.	FGE	Class II	1998-06-09
K980494	Supergloves	Supermax Sdn Bhd	LYY	Class I	1998-06-09
K980375	Winscan Automated Imaging System	Applied Imaging Corp.	JOY	Class II	1998-06-09
K974583	Deeglite	Grass-Telefactor Product Group	OLV	Class II	1998-06-09
K981840	CO2	Abbott Medical	KHS	Class II	1998-06-08
K981622	Dade Tru-Liquid Cardiac Control	Siemens Healthcare Diagnostics Inc.	JJX	Class I	1998-06-08
K981581	Iron	Abbott Medical	CFM	Class I	1998-06-08
K981560	Implex Continuum Knee System: Porous Tibial Component Model Number 05-230 System	Implex Corp.	JWH	Class II	1998-06-08
K981543	Olympus Lf-Tp and Lf-Dp Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment	Olympus Optical Co., Ltd.	EOQ	Class II	1998-06-08
K981216	Amy	Abbott Medical	JFJ	Class II	1998-06-08
K981027	E.cam Lso 311 Pet/spect System	Siemens Medical Solutions USA, Inc.	KPS	Class II	1998-06-08
K980970	Iirad Directray Operator Console	Sterling Diagnostic Imaging, Inc.	LLZ	Class II	1998-06-08
K980946	Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump	Dentsleeve Pty., Ltd.	FFX	Class II	1998-06-08
K980904	Mucheck Monitor Unit Validation Program	Medical Dosimetry Services, Inc.	IYE	Class II	1998-06-08
K974880	Perception Gps-Rst Diagnostic Ultrasound System	Perception, Inc.	IYO	Class II	1998-06-08