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 3331 of 3528

510(k) clearances, page 3331 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802440	Argyle Compact Chest Drainage Sys.	Sherwood Medical Co.	GCX	Class II	1980-10-23
K802435	Ucg-Beta Slide	Armkel, LLC	JHJ	Class II	1980-10-23
K802430	Nebulizer, Medicinal	Dhd Medical Products Div. Diemolding Corp.	EPN	Class I	1980-10-23
K802429	Cotton Rolls	Worldwide Surgical Gauze	EFN	Class I	1980-10-23
K802428	Propper Sharpguard & Traypad Steril. Aid	Propper Mfg Co Inc	FRG	Class II	1980-10-23
K802426	Respo2 Oxygen Concentrator	Mada Medical Products, Inc.	CAW	Class II	1980-10-23
K802421	Ucg-Beta Stat	Armkel, LLC	JHJ	Class II	1980-10-23
K802417	Ab O2 Consumption Calculator 980	Siemens Elema AB	BZL	Class II	1980-10-23
K802416	Salem/resce Intubation Guide	Scientific Sales Intl., Inc.	BSR	Class I	1980-10-23
K802414	Umbili-Cath Catheter	Int'L Corp.	FOS	Class II	1980-10-23
K802408	E-Vac Blood Culture System	Pfizer Pharmaceuticals	JSC	Class I	1980-10-23
K802404	Ortho Bovine Albumin Solution 30% Prote	Ortho Diagnostics, Inc.	DCF	Class II	1980-10-23
K802399	Model 2500 Pneumatic Percussor	Medical Equipment Development Co., Inc.	BYI	Class II	1980-10-23
K802397	Anaerobe Blood Agar	Granite Diagnostics, Inc.	JSG	Class I	1980-10-23
K802392	Astra Printer Paper #88112-Chloride Silv	Hi Chem, Inc.	JJF	Class I	1980-10-23
K802376	Kodak Ekta-Chem Clinical Chem. Slides	Eastman Kodak Company	CHS	Class II	1980-10-23
K802371	Uric Acid/aldh	Boehringer Mannheim Corp.	CDO	Class I	1980-10-23
K802367	Arrow Catheter Clamp	Arrow Intl., Inc.	KGZ	Class I	1980-10-23
K802365	Ohio Radiant Warmer	Ohio Medical Products	FMT	Class II	1980-10-23
K802350	Attenu-Chek	Hear Co., Inc.	EWO	Class II	1980-10-23
K802325	Criterion II Pacing System Monitors	Dart Medical Equipment	DRT	Class II	1980-10-23
K802318	Argyle Silicone Thoracic Catheter	Sherwood Medical Co.	GBS	Class I	1980-10-23
K802311	Mo8 Oxygen Flowmeter	Timeter Instrument Corp.	CAX	Class I	1980-10-23
K802310	Il Total Protein Reagent	Instrumentation Laboratory Co.	CEK	Class II	1980-10-23
K802301	Cordis Dow Infusion Pump	Cordis US Corp.	FRN	Class II	1980-10-23
K802300	Vivonex Jejunostomy Kit	Norwich Eaton Pharmaceuticals, Inc.	KNT	Class II	1980-10-23
K802286	Argle Latex Penrose Tubing	Sherwood Medical Co.	KGZ	Class I	1980-10-23
K802284	Antisera to Human Free Lambda Light Ch.	Kallestad Laboratories, Inc.	CZQ	Class II	1980-10-23
K802283	Antisera to Human Free Kappa Chains	Kallestad Laboratories, Inc.	DFH	Class II	1980-10-23
K802276	Fta-ABS Biopak	Bioware Products	JWL	Class II	1980-10-23
K802271	The Immobilizer for Open & Arthroscopic	The Anspach Effort, Inc.	BWN	Class I	1980-10-23
K802266	Hgb3 (1:251)	R & D Systems, Inc.	GKR	Class II	1980-10-23
K802259	Transvenous Pacemaker Electrode Kit	Stanco Medical, Inc.	LDF	Class II	1980-10-23
K802256	Triglycerides Determination	Coleman Laboratories	CDT	Class I	1980-10-23
K802251	Sp 120 Sophisticate	Vickers America Medical Corp.	JQP	Class I	1980-10-23
K802246	Analyte T3 Uptake	Technicon Instruments Corp.	KHQ	Class II	1980-10-23
K802218	Sd-900 Oscillometric Bp Monitor	Industrial & Biomedical Sensors Corp.	DXN	Class II	1980-10-23
K802217	View-Lite, Model-Sl	Med-Western Electronics, Inc.	IXC	Class I	1980-10-23
K802216	View-Lite, Model-Dl	Med-Western Electronics, Inc.	IXC	Class I	1980-10-23
K802215	View-Lite, Model-S	Med-Western Electronics, Inc.	IXC	Class I	1980-10-23
K802214	Cos-Uphoff Int'l Ds-5 Drainage System	Cox-Uphuff Intl.	GCY	Class I	1980-10-23
K802211	Serum Separator	Scientific Specialties, Inc.	JKA	Class II	1980-10-23
K802209	Surety Column	Scientific Specialties, Inc.	JKA	Class II	1980-10-23
K802206	Omni Scanner CT 6000	Omnimedical	JAK	Class II	1980-10-23
K802202	Sd-800 Blood Pressure Monitor	Industrial & Biomedical Sensors Corp.	DXN	Class II	1980-10-23
K802201	Sd-700 Blood Pressure Monitor	Industrial & Biomedical Sensors Corp.	DXN	Class II	1980-10-23
K802200	Vertix 3D-U	Siemens Corp.	KPR	Class II	1980-10-23
K802195	Dehydroepiandrosterone Sulfate Kit Ria	Radioassay Systems Laboratories, Inc.	JKC	Class I	1980-10-23
K802194	Minocycline 30Mcg. Sensi Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1980-10-23
K802190	Model 633A Three Channel Stress Test	Quinton, Inc.	DPS	Class II	1980-10-23