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 1868 of 3531

510(k) clearances, page 1868 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972871	Genesis	Pacific Rim Dental, Inc.	ELW	Class II	1997-10-02
K972723	Bio Trol	Mindmedia Labs, Inc.	HCC	Class II	1997-10-02
K972525	Thumper	Michigan Instruments	DRM	Class II	1997-10-02
K972515	Sensor Amplifier	Pro-Tech Services, Inc.	GWL	Class II	1997-10-02
K972445	Pulpdent Ox-Out	Pulpdent Corporation	EMA	Class II	1997-10-02
K971733	2 Bond 2	Kulzer GmbH	KLE	Class II	1997-10-02
K971004	Medcorp Flow i.v. Regulator Extension Set	Medcorp Intl.	FPA	Class II	1997-10-02
K973362	Needle Guide/grid	Protek Medical Products, Inc.	ITX	Class II	1997-10-01
K973316	Rep Spe Vis-60/40 Kit	Helena Laboratories, Corp.	CEF	Class I	1997-10-01
K973054	Ethyl Alcohol Clinical Standard Solutions	EMD Millipore Corporation	DNN	Class II	1997-10-01
K972891	Abuscreen Online for Amphetamines with Periodate - Olympus Au800/1000 Instrument Application	Roche Diagnostic Systems, Inc.	DKZ	Class II	1997-10-01
K972886	Mirage	Segami Corporation	LLZ	Class II	1997-10-01
K972718	M-2 Anterior Plate System	Acromed Corp.	KWQ	Class II	1997-10-01
K972712	Core Resistant Huber Infusion Sets	Abbott Medical	FPA	Class II	1997-10-01
K972703	Redyrob-Closed Wound Drainage System	B.Braun Medical, Inc.	GCY	Class I	1997-10-01
K972685	Origin Ligator Device	Origin Medsystems, Inc.	GCJ	Class II	1997-10-01
K972662	Cryogen Cryosurgical System	Cryogen, Inc.	GEH	Class II	1997-10-01
K972637	Precedent Revision Hip System	Sulzer Orthopedics, Inc.	LZO	Class II	1997-10-01
K972635	Ultracell Suction Sponge	Ultracell Medical Technologies, Inc.	GBX	Class I	1997-10-01
K972617	Helax-Visir	Helax AB	IYE	Class II	1997-10-01
K972597	Pmt New Beginnings Gelshapes & Amend	PMT Corp.	MDA	Class I	1997-10-01
K972584	Stryker Hummer II Microdebrider System	Stryker Corp.	ERL	Class II	1997-10-01
K972579	High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with Povidone-Iodine	Baxter Healthcare Corporation	KDJ	Class II	1997-10-01
K972578	Endopath Optiview Optical Surgical Obturator and Sleeve	Ethicon Endo-Surgery Inc	GCJ	Class II	1997-10-01
K972570	Heartport Introducer Sheath	Heartport, Inc.	DYB	Class II	1997-10-01
K972530	Convatec Odor Control Wound Dressing	Convatec, A Division of E.R. Squibb & Sons	KMF	Class I	1997-10-01
K972521	Navigator (Stylet) 2006	Sil-Med Corp.	GAH	Class I	1997-10-01
K972506	Infinitech Bullet Endo Illuminated Pick Manipulator	Infinitech, Inc.	HJM	Class II	1997-10-01
K972501	Apollo Revision/constrained Knee System	Sulzer Orthopedics, Inc.	JWH	Class II	1997-10-01
K972494	Depuy Dupont Absorbable Set Screw	Depuy, Inc.	HWC	Class II	1997-10-01
K971935	B&d Activated Clotting Time (Act) Test Tubes Bd-C101 (Diatomaceous Earth) and Bd-K101 (Kaolin)	B & D Corp.	JBP	Class II	1997-10-01
K971760	Colorpoint or Professional Colorpoint	Seiko Instruments USA, Inc.	LMC	Class II	1997-10-01
K971523	Distally Fixed Hip Stem	Sulzer Orthopedics, Inc.	MEH	Class II	1997-10-01
K971184	Oxi-Snap	Snap Laboratories, LLC	MNR	Class II	1997-10-01
K970912	Leibinger Self-Drilling Screw	Howmedica Leibinger, Inc.	HWC	Class II	1997-10-01
K960513	Peract 20 Liquid Sterilant	Medivators Inc	MED	Class II	1997-10-01
K973490	Sunglasses	Tong Yang Optical Co.	HQY	Class I	1997-09-30
K973407	Sunglasses (Non-Prescription)	Pacific Optical Co., Ltd.	HQY	Class I	1997-09-30
K972693	Deroyal Industries, Inc. Surgical Eye Spear	DeRoyal Industries, Inc.	HOZ	Class II	1997-09-30
K972522	Ml-Disposable Pak	Med-logics Inc	MSR	Class II	1997-09-30
K972440	Cataractscreener CT - S	Neitz Instruments Company, Ltd.	HKI	Class II	1997-09-30
K970854	5 Fr and 6 Fr Infiniti Angiographic Catheter	Cordis US Corp.	DQO	Class II	1997-09-30
K970650	Asahi Am-R Series Dialyzers	Asahi Kasei Medical MT Corp. Oita Works	MSE	Class II	1997-09-30
K973451	Mas Liquid Urinalysis Control Level 1, Level 2 and Level 3	Medical Analysis Systems, Inc.	JJW	Class I	1997-09-29
K973286	ENT Irrigating Pump (70327700)	Gyrus Ent LLC	ERL	Class II	1997-09-29
K973273	Xomed T-Stent, Frontal Sinus Stent	Xomed, Inc.	KAM	Class I	1997-09-29
K973256	Jimmy John III Rectal Nozzle	Colon Therapeutics	KPL	Class II	1997-09-29
K973189	Retinol Binding Protein Rbp Rid Kit	The Binding Site	CZS	Class I	1997-09-29
K973186	Immulite Cat-Specific Ige, Immulite Dog-Specific Ige,immulite Mite-Specific Ige	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1997-09-29
K973100	Prostate Specific Antigen (Psa) Calibrator	Dade Chemistry Systems, Inc.	JIT	Class II	1997-09-29