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 2042 of 3531

510(k) clearances, page 2042 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K953949	Humidifier & Accessories	Fisher & Paykel Electronics, Ltd.	CAW	Class II	1995-10-16
K953738	Erbotom Icc 300	Erbe Electromedizin GmbH	GEI	Class II	1995-10-16
K953691	Ms Classique Balloon Catheter W/hydropass Coating	Meadox Medicals, Div. Boston Scientific Corp.	EZN	Class II	1995-10-16
K953409	Laparoscopic Trocar	Core Dynamics, Inc.	GCJ	Class II	1995-10-16
K953351	Seatronics Family of Galvanic Oxygen Sensors	Seatronics Co.	CCL	Class II	1995-10-16
K953089	I-Spouse	Products for Medicine	LYU	Class I	1995-10-16
K952917	Steri-Oss Immediate Placement Implant	Steri-Oss, Inc.	DZE	Class II	1995-10-16
K951882	Eco Check (Ecovalve and Oxygen Monitor)	Airsep Corp.	CAW	Class II	1995-10-16
K951769	Cryopress	Grimm Scientific Industries, Inc.	IRP	Class II	1995-10-16
K951754	Culture Media, Antimicrobial Susceptibility Test	Hardy Diagnostics	JSO	Class II	1995-10-16
K950889	Adel 5000	Stryker Corp.	HDD	Class II	1995-10-16
K950750	Medelas Breast Pump	Medela AG	HGX	Class II	1995-10-16
K950587	Ecotabs	Msb, Ltd.	DRX	Class II	1995-10-16
K943412	Venturi Ventilator	Cardiopulmonary Corp.	CBK	Class II	1995-10-16
K954462	Polykote Powder Free Sterile Latex Surgeons Gloves	Intl. Trade Management Co.	KGO	Class I	1995-10-13
K954364	Cameo Home Pregnancy Test	Ortho-Clinical Diagnostics, Inc.	LCX	Class II	1995-10-13
K954344	Russon Industries Furniture Quality Wheelchair	Russon Industries	IOR	Class I	1995-10-13
K954321	Endocare Monopolar Electrodes (Modification)	Cytocare, Inc.	GEI	Class II	1995-10-13
K954266	Stc Diagnostics Auto-Lyte Creatinine Assay	Solarcare Technologies Corp,Inc.	CGX	Class II	1995-10-13
K954261	Landeez All-Terrain Wheelchair	Natural Access	IOR	Class I	1995-10-13
K954117	Customcare Seating System	Span-America Medical Systems, Inc.	KIC	Class I	1995-10-13
K954044	Sidekick Power Wheelchair	21ST Century Scientific, Inc.	ITI	Class II	1995-10-13
K953655	J-Vac Suction Reservoirs & J-Vac Blake Silicone Drains	Johnson & Johnson MEDICAL GmbH	OCX	Class II	1995-10-13
K953593	Rusch Tracheal Bronchial Y Stent	Rusch, Inc.	NYT	Class II	1995-10-13
K953448	Roche Cobas Micros Hematology Analyzer	Roche Diagnostic Systems, Inc.	GKZ	Class II	1995-10-13
K953447	Precisionist Thirty Thousand	Paradigm Medical Industries, Inc.	HQC	Class II	1995-10-13
K952765	Delwa-Star Pacifier Thermometer	Zewa, Inc.	FLL	Class II	1995-10-13
K952488	Trace Cobas Mira Range	Trace Scientific, Ltd.	CIX	Class II	1995-10-13
K951639	Complement Activation Eia Test System (Cae)	Incstar Corp.	DAE	Class II	1995-10-13
K951363	Cardiolipin Igg,m,a Eia Test System	Immunoprobe, Inc.	MID	Class II	1995-10-13
K950617	Smart Wave Gs100	Shotwell & Carr, Inc.	IPF	Class II	1995-10-13
K950305	Qtmicro(tm) System	Q.I. Medical, Inc.	LHI	Class II	1995-10-13
K941342	Pain Doc	Regulatory & Marketing Services, Inc.	GZB	Class II	1995-10-13
K935456	Regulus Measurement Unit	Compass Intl., Inc.	HAW	Class II	1995-10-13
K954362	Argistar 74	Argen Precious Metals, Inc.	EJT	Class II	1995-10-12
K954333	American Dental Products Orthodontic Adhesive W/one Step Bonding System	American Dental Products, Inc.	DYH	Class II	1995-10-12
K954244	American Dental Products Light Activated Orthodontic Adhesive Bonding System W/fluoride	American Dental Products, Inc.	DYH	Class II	1995-10-12
K954069	Ace Cervical Traction Halozs, Tongs & Pins	Ace Medical	HAX	Class II	1995-10-12
K953818	Dall-Miles Suture/beaded Cable	Howmedica Corp.	JDQ	Class II	1995-10-12
K953776	Steriking Sterilization Pouches & Rolls	Wihuri Oy	KCT	Class II	1995-10-12
K953740	For Med High Risk	For Med, Inc.	LYY	Class I	1995-10-12
K953712	Derrick Sureshield	M.P.S. Pharm'L Int'L	KGO	Class I	1995-10-12
K953685	Instrument Scope	Clarus Medical Systems, Inc.	GWG	Class II	1995-10-12
K953639	Neutralon Brown Latex Surgical Gloves	Johnson & Johnson MEDICAL GmbH	KGO	Class I	1995-10-12
K953479	Bipolar Forceps	Megadyne Medical Products, Inc	GEI	Class II	1995-10-12
K953449	Model 1207, Hydrodot Neuromonitoring System Adhesive Pads	Physiometrix, Inc.	GWQ	Class II	1995-10-12
K953394	Visitec Collar Button Catheter {Griffiths}	Visitec Co.	LZU	Unclassified	1995-10-12
K952588	Royal Shield Non-Sterile Latex Examination Gloves	Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.	LYY	Class I	1995-10-12
K952473	Powder-Free Latex Examination Glove	M.M.R. Gloves Private, Ltd.	LYY	Class I	1995-10-12
K951981	Rxair 3000	Clean Air Research & Development	FRA	Class II	1995-10-12