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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3249 of 3528

510(k) clearances, page 3249 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K813485	Sas Educational Chart	Structural Analysis Systems, Inc.	IOL	Class I	1982-01-29
K813456	High Voltage Galvanic Stimulator 550	Chattanooga Group, Inc.	IPF	Class II	1982-01-29
K813385	Digital Blood Pressure Unit	Conphar, Inc.	DXN	Class II	1982-01-29
K813378	Uni-Bite Dental X-Ray Film Holder	Rinn Corp.	EGZ	Class I	1982-01-29
K813340	Hip Pin	The Deca Co.	KTW	Class II	1982-01-29
K813266	Nihon Kohden Electrocardiograph	Nihon Kohden America Inc	DRS	Class II	1982-01-29
K812837	Alkaline Phosphatase Reagent Set	Anco Medical Reagents & Assoc.	CJL	Class II	1982-01-29
K820151	Philly Infant Bolt	Philadelphia Medical Specialties	GWN	Class II	1982-01-28
K820138	Primidone Reagent Test Kit	Beckman Instruments, Inc.	DJD	Class II	1982-01-28
K820132	Babybird 2 Ventilator	3M Company	CBK	Class II	1982-01-28
K820131	3M Volume Ventiator Circuit	3M Company	BZO	Class I	1982-01-28
K820103	Pathway Ph Blood Gas Control	Beckman Instruments, Inc.	JJS	Class I	1982-01-28
K820090	Astra-T Calcium Reagent	Hi Chem, Inc.	CIC	Class II	1982-01-28
K820089	Tsh (Ria) Kit	Immuno Assay Corp.	JLW	Class II	1982-01-28
K820086	Curity Surgical Scrub Brush Sponge	The Kendal Co.	GEC	Class I	1982-01-28
K820083	Sutter Cpm	Sutter Biomedical, Inc.	BXB	Class I	1982-01-28
K820082	Post-Op Electrode (TENS Electrode)	Consolidated Medical Equipment Company	GXY	Class II	1982-01-28
K820077	Emerson Thoracic Suction Reg. #55-Jp	J. H. Emerson Co.	KDP	Class II	1982-01-28
K820074	Cortisol (Ria) Kit	Immuno Assay Corp.	CGR	Class II	1982-01-28
K820071	Model 5790 Gas Chromatograph	Hewlett-Packard Co.	KZQ	Class I	1982-01-28
K820068	Cold-Hot Pack	Hospital Marketing Services Co., Inc.	IME	Class I	1982-01-28
K820064	Susceptrol	American Type Culture Collection	JTR	Class I	1982-01-28
K820060	Campylobacter Thioglycollate Med W/5	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1982-01-28
K820043	Tek-Pro Tek-Tator V Rotator & Humidify	American Dade	LIB	Class I	1982-01-28
K820040	Sc-It Impedance Tester	Cadwell Laboratories, Inc.	GYA	Class I	1982-01-28
K820010	Gas Generating Kit, CO2	Oxoid U.S.A., Inc.	KZJ	Class I	1982-01-28
K813649	Pbc Needle	Philadelphia Biologics Center	FMI	Class II	1982-01-28
K813648	Jms Needle & Mac Ject	Philadelphia Biologics Center	FMI	Class II	1982-01-28
K813646	Jms Disposable Syringe	Philadelphia Biologics Center	FMF	Class II	1982-01-28
K813640	Miniwash II	Dynatech Corp.	LIB	Class I	1982-01-28
K813590	Model As6b Infusion Pump	Baxter Healthcare Corporation	FRN	Class II	1982-01-28
K813564	Coag-a-Mate X2	General Diagnostics	GKP	Class II	1982-01-28
K813458	Fetascan 1000, 1000A Obstetrical Data	Cranbury Medical Labs, Inc.	HGM	Class II	1982-01-28
K813451	Uva Fluorescent Tanning Lamps	North American Philips Corp.	IOB	Class II	1982-01-28
K813338	Biopsy Needles & Trays	American Pharmaseal Div. Ahsc	FSH	Class I	1982-01-28
K813337	Skinny Chiba Needle & Tray	American Pharmaseal Div. Ahsc	FSH	Class I	1982-01-28
K813306	Conphar Digital Thermometer	Conphar, Inc.	FLL	Class II	1982-01-28
K813239	Oxygenaire Nuring Incubator	Vickers America Medical Corp.	FMZ	Class II	1982-01-28
K813205	Intersept Cardiotomy Reservoir/filter	Extracorporeal Medical Specialities, Inc.	DTB	Class III	1982-01-28
K813204	Seracult Occult Bloof Test	Propper Mfg Co Inc	KHE	Class II	1982-01-28
K813187	Pilling Lacrimal Intubation System	Narco Scientific	HNL	Class I	1982-01-28
K812524	Piperacillin 100 Mcg. Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1982-01-28
K812435	Datapass	General Electric Co.	IYO	Class II	1982-01-28
K820088	Aft System Proficiency Testing Program	Calbiochem-Behring Corp.	DBL	Class II	1982-01-26
K820075	Seralyzer Creatinine Reagent Strips	Miles Laboratories, Inc.	CGX	Class II	1982-01-26
K813603	Linqual-Oral Training Splint	Charles F. Samelson, M.D.			1982-01-26
K813347	Critikon Transcutaneous Gas Monitors	Critikon Company, LLC	KLK	Class II	1982-01-26
K813221	Toxoelisa Test Kit	M.A. Bioproducts	LGD	Class II	1982-01-26
K813011	Hepaquant	Streck Laboratories, Inc.	JOX	Class II	1982-01-26
K812804	Modern Materials' Inlay Cstg. Waxes,a-C	Modern Materials	EGD	Class I	1982-01-26