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 1888 of 3531

510(k) clearances, page 1888 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972078	Post-Stop Epistaxis Catheter	Boston Medical Products, Inc.	EMX	Class I	1997-07-10
K972006	Acta Oem Module	Interactive Consulting, Inc.	EBZ	Class II	1997-07-10
K971722	Trans Vaginal Needle Guide	Protek Medical Products, Inc.	ITX	Class II	1997-07-10
K971546	Soma 900 Transport Bed	Nova Technologies, Inc.	FNL	Class II	1997-07-10
K971191	Far-East Shoe Covers	Far East Science & Technology Development Co., Ltd.	FXP	Class I	1997-07-10
K970988	Far-East Bouffant Caps	Far East Science & Technology Development Co., Ltd.	LYU	Class I	1997-07-10
K970371	Flotec Oxysavrr (S)	Flotec, Inc.	NFB	Class II	1997-07-10
K970051	Musclesense II Clinical Electromyography Device	Smith and Nephew Donjoy, Inc.	HCC	Class II	1997-07-10
K965079	Somnitor 32K Sleep Activity Monitor	Neurim Pharmaceuticals, Ltd.	LEL	Class II	1997-07-10
K964190	Era 300 Dual Chamber Pacing System Analyzer	BIOTRONIK AG	DTE	Class II	1997-07-10
K972269	Disposable Patient Return Electrode	Erbe USA Inc	GEI	Class II	1997-07-09
K972026	Sp4044 & Sp4055 Lux Modules	Satelec	ELC	Class II	1997-07-09
K971815	Asc Balance Middleweight Guide Wire	Boston Scientific Corporation	DQX	Class II	1997-07-09
K971700	Biopsy Accessory for Ultrasound Transducer	Biosound, Inc.	ITX	Class II	1997-07-09
K971654	Osteo Compression Hip Screw System	Osteonics Corp.	HWC	Class II	1997-07-09
K971435	Headloc Ceramic Femoral Heads	Ortho Development Corp.	LZO	Class II	1997-07-09
K971429	Interseal Acetabular Screw Hole Plug	Wrightmedicaltechnologyinc	LPH	Class II	1997-07-09
K971426	Headloc Ceramic Head	Ortho Development Corp.	LZO	Class II	1997-07-09
K971409	Osteonics Alumina C-Taper Head	Osteonics Corp.	LZO	Class II	1997-07-09
K971404	Schwartz Electro-Optics, Inc. Clr 2940/Erbium Crystalase (Formerly Trilase 2940 Erbium Laser	Schwartz Electro-Optics, Inc.	GEX	Class II	1997-07-09
K971381	Powder-Free Duraprene Sterile Synthetic Surgical Gloves	Medtronic, Inc.	KGO	Class I	1997-07-09
K971358	Bio-Interference Screw, 7 Mm, 8 Mm, 9 Mm	Arthrex GmbH	MAI	Class II	1997-07-09
K971337	Epitech Island Dressings	Rynel, Ltd. Inc.	KMF	Class I	1997-07-09
K971332	Ams Mainstay Urologic Bone Anchor	American Medical Systems, Inc.	MBI	Class II	1997-07-09
K971321	Osteo Compression Condyle Screw System	Osteonics Corp.	HRS	Class II	1997-07-09
K971194	Nihon Kohden Tec-6100A Cardiolife Mini Defibrillator & Accessories	Nihon Kohden America Inc	LDD	Class II	1997-07-09
K971079	Interlogics W-Tracker and Wrist Works Software	Interlogics, Inc.	KQX	Class I	1997-07-09
K971070	Scarf Thread-Head (Tm) Head Screw	Landos, Inc.	HWC	Class II	1997-07-09
K971069	Twist-Off (Tm) Screw	Landos, Inc.	HWC	Class II	1997-07-09
K971068	34Mm Scarf Thread-Head(tm) Screw	Landos, Inc.	HWC	Class II	1997-07-09
K970236	Theraplan Plus Version 1.2	Theratronics, Inc.	IYE	Class II	1997-07-09
K970011	Escort II Clinical Thermometry Module (Ctm)	Medical Data Electronics	FLL	Class II	1997-07-09
K964920	Rpi Dual Port Irrigation Adapter	Ridge Products, Inc.	KNT	Class II	1997-07-09
K972273	Tbd	Megadyne Medical Products, Inc	GEI	Class II	1997-07-08
K972146	Qualitrol Unassayed H. Pylori Control Set Positive and Negative Controls	Consolidated Technologies, Inc.	LYR	Class I	1997-07-08
K972092	Nasal Airway Splint	Boston Medical Products, Inc.	LYA	Class I	1997-07-08
K972001	Nicas(tm) Electrode	Ni Medical	DRX	Class II	1997-07-08
K972000	X-Ray Assist Bar	Ralph Lindel, D.C.	KPR	Class II	1997-07-08
K971702	Far-East Barrier Gowns	Far East Science & Technology Development Co., Ltd.	FYC	Class II	1997-07-08
K971550	Kinematic All-Polyethylene Patella with Three Pegs	Howmedica Corp.	JWH	Class II	1997-07-08
K971342	Disk Whisk Cutting Device (Conical, Elliptical and Ball Head)	Disk Whisk, Inc.	HWE	Class I	1997-07-08
K970739	Rmi Hemoconcentrator Preference Pack	Research Medical, Inc.	KDI	Class II	1997-07-08
K961732	Kar	Landos, Inc.	MEH	Class II	1997-07-08
K972287	Dade Tru-Liquid Bilirubin Control	Dade Intl., Inc.	JJX	Class I	1997-07-07
K972151	Doyle Combo Nasal Airway Splint	Boston Medical Products, Inc.	LYA	Class I	1997-07-07
K971473	Ivalon Instrument Wipe, Ivalon Knife Cleaning Block	M-Pact Worldwide Management Corp.	GEC	Class I	1997-07-07
K971349	Biosign Strep a - Direct Strep a Antigen Test	Princeton BioMeditech Corp.	GTY	Class I	1997-07-07
K971302	Ultracision 5Mm Laparosonic Hook Blades, Ultracision Hs2 Blade	Ethicon Endo-Surgery Inc	LFL	Unclassified	1997-07-07
K971060	Precinorm Tdm Controls	Boehringer Mannheim Corp.	DIF	Class I	1997-07-07
K970995	Cms Cryolite	Cryomedical Sciences, Inc.	GEH	Class II	1997-07-07