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 1864 of 3531

510(k) clearances, page 1864 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K970742	Tritest Cd3 Fitc/cd19 Pe/cd45 Percp Reagent with Trucount Absolute Count Tubes	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1997-10-22
K973811	Powder-Free Latex Examination Glove, Teal or White (Non-Colored)	Absolute Quality Leadership, Inc.	LYY	Class I	1997-10-21
K973572	Kelocote Scar Gel and Kelocote Laser Gel	Hanson Medical, Inc.	MDA	Class I	1997-10-21
K973492	Dentalview Perioview System	Dentalview, Inc.	EIA	Class I	1997-10-21
K973343	Hydroflex	GC America Inc.	ELW	Class II	1997-10-21
K973283	Alginate/zinc Wound Dressing	Innovative Technologies, Ltd.	KMF	Class I	1997-10-21
K973260	Hydrasorb Sterile Dressing	Avitar, Inc.	MGP	Unclassified	1997-10-21
K973110	Ludlow Technical Products, Electrode, Electrosurgical, Disposable Pediatric Dispersive Electrodes; with and without Cord	Ludlow Technical Products	GEI	Class II	1997-10-21
K972978	Vista Brite Tip Guiding Catheters	Cordis US Corp.	DQY	Class II	1997-10-21
K972837	Npb-290 Pulse Oximeter (Npb-290)	Medtronic, Inc.	DQA	Class II	1997-10-21
K972832	Provision Surgical Helmet System	Depuy, Inc.	FYA	Class II	1997-10-21
K972801	Alliance Rubber, Ec-Grip	Alliance Rubber Products Sdn. Bhd.	LYY	Class I	1997-10-21
K972770	Advance Ultra-Congruent Tibial Insert	Wrightmedicaltechnologyinc	JWH	Class II	1997-10-21
K972765	Nuvolase 720 System for Ophthalmology Laser	American Laser Medical	GEX	Class II	1997-10-21
K972752	Duracon Conversion Metal Backed Patella	Howmedica Corp.	JWH	Class II	1997-10-21
K972746	Alexander Manufacturing Co. Rechargeable Battery Part Number Lp6/100	Alexander Mfg. Co.	DPS	Class II	1997-10-21
K972745	Titanium Hemostatic Clip	Eisner USA, Inc.	MCH	Class II	1997-10-21
K972481	Auto-Lyte Cotinine Eia	OraSure Technologies, Inc.	MKU	Class I	1997-10-21
K972277	Digiflex Surgical Gloves	Hms Services, Inc.	KGO	Class I	1997-10-21
K972093	Regenesis Model 42	Regenesis Biomedical Inc	ILX	Class II	1997-10-21
K972071	Bovie Model X40	Maxxim Medical	GEI	Class II	1997-10-21
K971897	Continuous Arteriovenous Hemofiltration Catheter 10 Fr (Cavh)	Medron, LLC	LFK	Class II	1997-10-21
K971672	Seraquest Toxoplasma Igm	Quest Intl., Inc.	LGD	Class II	1997-10-21
K971436	Nihon Kohden Tec-7511A/tec-7521A Cardiolife Portable Defibrillator and Accessories	Nihon Kohden America Inc	LDD	Class II	1997-10-21
K971392	Histofreezer Verruca Plana	OraSure Technologies, Inc.	GEH	Class II	1997-10-21
K963858	Femassist Urinary Device	Insight Medical Corp.	MNG	Class I	1997-10-21
K973668	Cardiac Troponin-I (Trop) Calibrator	Dade Intl., Inc.	JIT	Class II	1997-10-20
K973650	Troponin (Trop) Method	Dade Chemistry Systems, Inc.	MMI	Class II	1997-10-20
K973535	Ace Carbamazepine Reagent/aed Calibrators	Schiapparelli Biosystems, Inc.	KLT	Class II	1997-10-20
K973440	Rexam Fracture Resistant Pouch	Rexam Medical Packaging, Inc.	KCT	Class II	1997-10-20
K973292	I-Stat System	I-Stat Corp.	CGL	Class II	1997-10-20
K973208	First Sign	Texas Immunology, Inc.	LCX	Class II	1997-10-20
K973142	Dbest Reagent Strip for Urinalysis	Ameritek, Inc.	JIL	Class II	1997-10-20
K973022	Island Biosurgical Inc. Bns Kit #1 & #2	Island Biosurgical, Inc.	OTN	Class II	1997-10-20
K973014	Quanta Lite B2gpi Igm	Inova Diagnostics, Inc.	MSV	Class II	1997-10-20
K973006	Quanta Lite B2 Gpi Iga	Inova Diagnostics, Inc.	MSV	Class II	1997-10-20
K972929	N Antiserum to Human Albumin	Behring Diagnostics, Inc.	DCF	Class II	1997-10-20
K972780	Alexander Manufacturing Co. Rechargeable Battery Part Number Gl625	Alexander Mfg. Co.	MRZ	Class II	1997-10-20
K972779	Alexander Manufacturing Co. Rechargeable Battery Part Number Ms3030-P	Alexander Mfg. Co.	MRZ	Class II	1997-10-20
K972763	Hemaprompt	Aerscher Diagnostics	KHE	Class II	1997-10-20
K972260	Cs-400 Coagulation Analyzer System (A1208)	Sigma Diagnostics, Inc.	JPA	Class II	1997-10-20
K972257	N-Assay Tia Antithrombin III Test Kit	Crestat Diagnostics, Inc.	DDQ	Class II	1997-10-20
K972200	Aneuvysion	Vysis	OYU	Class II	1997-10-20
K971985	N-Assay Tia Plasminogen Test Kit	Crestat Diagnostics, Inc.	GGP	Class II	1997-10-20
K970893	Ultrasound Transducer Drape	Protek Medical Products, Inc.	FYA	Class II	1997-10-20
K970889	Ultrasound Transducer Drape	Protek Medical Products, Inc.	KKX	Class II	1997-10-20
K940583	Ventana Cd45 Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1997-10-20
K973368	Strait'map Option	GE Healthcare	IZI	Class II	1997-10-17
K972840	N Antiserum to Human Transferrin	Behring Diagnostics, Inc.	DDG	Class II	1997-10-17
K972818	D72 Digital	Philips Hearing Instruments Co.	ESD	Class I	1997-10-17