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 2026-10-15, 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 3156 of 3528

510(k) clearances, page 3156 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K831290	Electrode, Flexible Suction Coagulator	Aspen Laboratories, Inc.	GEI	Class II	1983-06-03
K831285	Surgical/lid Margin Cover & Eyelash-	Richard R. Anthony, M.D.	HOD	Class I	1983-06-03
K831261	Sci Med Tubing Connectors	Scimed Life Systems, Inc.	DTL	Class II	1983-06-03
K831260	Sci Med Temperature Monitoring Adaptor	Scimed Life Systems, Inc.	DTL	Class II	1983-06-03
K831251	Tumisensor 1524	Life-Tech Intl., Inc.	LIL	Unclassified	1983-06-03
K831233	Glenoid Resurfacing Component-3M-10816	3M Company	KWT	Class II	1983-06-03
K831203	Y-Type Backcheck Microbore Exten. Set	Abbott Medical	FRN	Class II	1983-06-03
K831142	Inspiratory Resistor Kit	Dhd Medical Products Div. Diemolding Corp.	BWF	Class II	1983-06-03
K830981	Micropak Moist Heat Pad	Micropak Manufacturers, Inc.	IME	Class I	1983-06-03
K830362	Infant Electrode Belt	Sentry Medical Products, Inc.	DRX	Class II	1983-06-03
K830321	Venture II Monitoring System	Rae Medical Corp.	DSF	Class I	1983-06-03
K830272	Protet Holders-Blocks & Roll	Ritmed, Inc.	FWZ	Class I	1983-06-03
K830264	Floret Tonsil & Adenoid Sponges	Ritmed, Inc.	EFQ	Unclassified	1983-06-03
K823770	Spirotech St-5500	Spirotech, Inc.	BZG	Class II	1983-06-03
K831541	Tub Transfer Bench Bk6481	Fred Sammons, Inc.	IKX	Class I	1983-06-02
K831485	Ventre/zyme Ige Kit	Ventrex Laboratories, Inc.	DGC	Class II	1983-06-02
K831450	Disposable Sterile Filter System	Corning Medical & Scientific	LIB	Class I	1983-06-02
K831433	Extrasensr Ultrafiltration Monitor	Extracorporeal Medical Specialities, Inc.	KOC	Class II	1983-06-02
K831425	Mdt Chemitest See-Thru Bag	Kenpak Converters, Inc.	FRG	Class II	1983-06-02
K831400	Ames Tda Procainamide Test	Miles Laboratories, Inc.	LAR	Class II	1983-06-02
K831399	Ames Tda N-Acetyl-Procainamide Test	Miles Laboratories, Inc.	LAN	Class II	1983-06-02
K831388	Glass Frames & Component Parts	Anamar	HQZ	Class I	1983-06-02
K831385	Lithotomy Chair #415	Midmark Corp	GBB	Class I	1983-06-02
K831377	Ige Radioimmunoassay Kit	American Diagnostic Corp.	DGC	Class II	1983-06-02
K831366	Testcorp Preg	Catheter Technology Corp.	JHJ	Class II	1983-06-02
K831365	Testcorp Ana	Catheter Technology Corp.	LKS	Class I	1983-06-02
K831361	Beta-Preg	Catheter Technology Corp.	JHJ	Class II	1983-06-02
K831357	Boundary Headwear	Procter & Gamble Mfg. Co.	FYF	Class I	1983-06-02
K831355	Emit Qst Quinidine Assay	Syva Co.	LBZ	Class II	1983-06-02
K831347	Microcapillary Infusion System	J.S. Biomedicals, Inc.	FFX	Class II	1983-06-02
K831342	Coat-a-Count No-Extraction Testosterone	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	1983-06-02
K831341	Api Uniscept Plus Autoinoculator	Analytical Products, Inc.	JTC	Class I	1983-06-02
K831326	Allercoat Allergen Discs	Kallestad Laboratories, Inc.	DGC	Class II	1983-06-02
K831325	Nutromat	Medlog GmbH Marketing Services	GBB	Class I	1983-06-02
K831304	Emit Qst Gentamicin Assay	Syva Co.	LCD	Class II	1983-06-02
K831299	Even-Temp. Capacitive Adhesive Pad	Delta Medical Electronics, Inc.	GEI	Class II	1983-06-02
K831291	Electrosurgical Unit-Mf 380 #60-1700	Aspen Laboratories, Inc.	GEI	Class II	1983-06-02
K831273	Qst Tm Sample Processor	Syva Co.	JQW	Class I	1983-06-02
K831236	Bipolar Card	New England Surgical Instrument Corp.	GEI	Class II	1983-06-02
K831234	Glenoid Resurface Component Pmn 3M	3M Company	KWT	Class II	1983-06-02
K831227	Compur Easy Touch Chemistry Analyzer-	Worthington Diagnostic Systems	JJF	Class I	1983-06-02
K831223	Beta-Quik-15 Ria Kit	Pacific Biotech, Inc.	JHI	Class II	1983-06-02
K831221	Riagen B-Hcg Ria Kit	Biogenex Laboratories, Inc.	JHI	Class II	1983-06-02
K831206	Arubi Flatter & Arubi Flatter-S	Kc Export Management Co.	ISA	Class I	1983-06-02
K831155	B-Clone Hcg Assay	Monoclonal Antibodies, Inc.	JHJ	Class II	1983-06-02
K831109	Duoclon Slide Test	Organon LLC	JHI	Class II	1983-06-02
K831009	Cantor Tube	Medovations, Inc.	KNT	Class II	1983-06-02
K830998	Miller-Abbott Tube	Medovations, Inc.	KNT	Class II	1983-06-02
K830997	Aria II I-Hcg	BD Becton Dickinson Vacutainer Systems Preanalytic	JHI	Class II	1983-06-02
K830991	Esophageal Bougies	Medovations, Inc.	KNQ	Class II	1983-06-02