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 1737 of 3531

510(k) clearances, page 1737 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990640	Velogene Rapid Mrsa Identification Assay	Id Biomedical Corp.	MYI	Class II	1999-07-09
K984295	Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus)	Invacare GmbH	CCL	Class II	1999-07-09
K983504	Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test St	Medisense, Inc.	CGA	Class II	1999-07-09
K992155	Volusion Small Parts Transducer, Model S-Vnw 5-10, Volusion Abdominal Transducer, Model S-Vaw 4-7	Medison America, Inc.	ITX	Class II	1999-07-08
K991807	Titanium Low Profile Screws	Zimmer GmbH	LPH	Class II	1999-07-08
K991590	C-Leg (3C100)	Otto Bock Orthopedic Industry, Inc.	ISW	Class II	1999-07-08
K991572	Isolux Surgical Headlight	Isolux America	FST	Class II	1999-07-08
K991342	Pbs 1X- Dulbecco's Phosphate Buffered Saline Solution	FUJIFILM Biosciences Inc.	MQL	Class II	1999-07-08
K991341	Isolate, Isolate Concentrate, Isolate Stock Solution	FUJIFILM Biosciences Inc.	MQL	Class II	1999-07-08
K991337	Sperm Maintenance Medium with Glycerol	FUJIFILM Biosciences Inc.	MQL	Class II	1999-07-08
K991263	Thermoplate	Tokai Hit Co., Ltd.	MQG	Class II	1999-07-08
K991238	Fci Crawford Probe Intubation Sets	Fci Ophthalmics, Inc.	OKS	Unclassified	1999-07-08
K991235	Softrans Temp Intrauterine Pressure Catheter System (Iup 5000, Softrans Temp Iupc)	Ludlow Technical Products	KXO	Class II	1999-07-08
K991225	Mti 1 Ml Syringe	Medtronic, Inc.	FMF	Class II	1999-07-08
K991211	Eventstation ECG Trans-Telephonic Receiving System	Reynolds Medical, Ltd.	DXH	Class II	1999-07-08
K990355	Stainless Steel Soft Suture Wire	Bregma International Trading Company, Ltd.	LRN	Class II	1999-07-08
K990234	Qualisys Psa Immunoassay	Qualisys Diagnostics, Inc.	LTJ	Class II	1999-07-08
K984033	Atlas Monitor	Welch Allyn Inc	DRT	Class II	1999-07-08
K983764	Viewpoint Tools- Sterrad	Philips North America LLC	HAW	Class II	1999-07-08
K992054	Adventure Tints Prosthetic Tinted Soft Contact Lens	Adventures in Color Technology, Ltd.	LPL	Class II	1999-07-07
K991852	Ocusystem Art Advantage, Model 995	Surgical Design Inc	HQC	Class II	1999-07-07
K991849	Non-Sterile Powder-Free Latex Examination Gloves with a Protein Labeling Claim (50 Micrograms or Less Total Water Extrac	Seal Polymer Industries Bhd.	LYY	Class I	1999-07-07
K991787	N Latex Ige Mono Reagent	Siemens Healthcare Diagnostics Inc.	DGC	Class II	1999-07-07
K991711	Bistite II Sc	Tokuyama America Inc.	EMA	Class II	1999-07-07
K991479	Viser Penile Tumescence Monitor	Laborie Medical Tech Corp.	LIL	Unclassified	1999-07-07
K990818	Rapidone - Marijuana Test	American Bio Medica Corp.	LDJ	Class II	1999-07-07
K984090	Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear, Speciality 55 (Methafilcon a)	Specialty Ultravision, Inc.	LPL	Class II	1999-07-07
K992105	Immulite Turbo Intact Pth, Model Lskptz	Siemens Healthcare Diagnostics Inc.	CEW	Class II	1999-07-06
K992068	Status Stik, Accusign Stik	Princeton BioMeditech Corp.	DKE	Class II	1999-07-06
K991955	Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection	Engineered Medical Systems, LLC	BTM	Class II	1999-07-06
K991537	Samsung Raypax System	Samsung Sds Co., Ltd.	LMD	Class I	1999-07-06
K991468	Immerge Image Correlation	Surgical Navigation Technologies, Inc.	LLZ	Class II	1999-07-06
K991434	Quadrature Wrist Coil, Model 445Ph-64	Medical Advances, Inc.	MOS	Class II	1999-07-06
K991323	Smith & Nephew Subcutaneous Illuminator	Smith & Nephew, Inc.	FFS	Class II	1999-07-06
K983518	Lifestyles Xtra Pleasure	Ansell, Inc.	HIS	Class II	1999-07-06
K982180	Duragen Dural Graft Matrix	Integra LifeSciences Corporation	GXQ	Class II	1999-07-06
K981938	Tampa Hyperbaric Monoplace Chamber	Tampa Hyperbaric Ent.	CBF	Class II	1999-07-06
K991626	Webrad Computed Radiography Quality Assurance Workstation	Analogic Corp.	LLZ	Class II	1999-07-02
K991421	Freezing Medium - Test Yolk Buffer (Tyb) with Glycerol, Refrigeration Medium - Test Yolk Buffer 9Tyb)	FUJIFILM Biosciences Inc.	MQL	Class II	1999-07-02
K991420	Modified Ham's F-10 with Albumin	FUJIFILM Biosciences Inc.	MQL	Class II	1999-07-02
K991170	Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-Rc-014	Edwards Lifesciences LLC	DWF	Class II	1999-07-02
K983768	Modification to Gamma Guidance System	Radiation Monitoring Devices, Inc.	IZD	Class I	1999-07-02
K982974	Dd Ureteral Stent, Integral Stent	Rusch Intl.	FAD	Class II	1999-07-02
K992058	Bi-Metric Ccocr Head/neck Replacement System	Zimmer GmbH	JDI	Class II	1999-07-01
K991953	Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection	Engineered Medical Systems, LLC	BTM	Class II	1999-07-01
K991939	Brightway Brand Nitrile Surgical Gloves - Sterile (Powder-Free)	Brightway Holdings Sdn. Bhd.	KGO	Class I	1999-07-01
K991821	Nitrile Examination Glove, Powdered, Blue	Ning BO Yujiang Rubber & Plastic Co.	LZA	Class I	1999-07-01
K991539	Excell 22	Mwi, Inc.	GKZ	Class II	1999-07-01
K991457	Disposable Vinyl Synthetic Exam Gloves, Powder Free	Shanghai Palomar Mountain Industries, Inc.	LYZ	Class I	1999-07-01
K991275	Walkmed 300, Walkmed 350, Walkmed Ic, Walkmed Pca, Walkmed Plus	Mckinley, Inc.	FRN	Class II	1999-07-01