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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2980 of 3529

510(k) clearances, page 2980 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852428	Manan Epidural Needle	Manan Manufacturing Co., Inc.	GCB	Class I	1985-06-27
K852427	Manan Spinal Needle	Manan Manufacturing Co., Inc.	GAA	Class I	1985-06-27
K852426	Manan Trocar Style Biopsy Needle	Manan Manufacturing Co., Inc.	GAA	Class I	1985-06-27
K852348	Philips Solarium Hp 3134	Philips Int'L B.V.	FTC	Class II	1985-06-27
K852330	Retractor, Surgical	Scholten Surgical Instruments, Inc.	GAD	Class I	1985-06-27
K852277	Catapress Tourniguet	Boehringer Ingelheim Pharmaceuticals, Inc.	GAX	Class I	1985-06-27
K852263	Phadebas Rast/phadezym Rast Allertubes	Pharmacia, Inc.	DHB	Class II	1985-06-27
K852258	Sure-Count 30 Count Magnetic Needle Counter	Kleen Test Products Corporation			1985-06-27
K852252	870 Surgical Sys Control Pulse Modification	Cooper Lasersonics, Inc.	GEX	Class II	1985-06-27
K852245	Stille Bone Cutting Rorceps 10 1/4 in Ss 420 & 416	The Huxley Instrument Corp.			1985-06-27
K852243	Kettler Ultraviolet Suntanning Benches & Lifts	Mottek Intl. Corp.	FTC	Class II	1985-06-27
K852087	Capiox Luer Design Thermistors & Capiox Connectors	Terumo Medical Corp.	FLL	Class II	1985-06-27
K852057	Ascon Surgical Instruments	Ascon Medical Instruments, Ltd.	HNR	Class I	1985-06-27
K851680	Ostomy Bags Ileostomy	Dbt Medical, Ltd.	EXB	Class I	1985-06-27
K851679	Ostomy Bags Colostomy	Dbt Medical, Ltd.	EXB	Class I	1985-06-27
K851678	Ostomy Bags Uretherostomy	Dbt Medical, Ltd.	EXB	Class I	1985-06-27
K851628	Rmg-9 9 Remote Monitor Access. for G-2000 Electro	Eaton Medical Group	DXJ	Class II	1985-06-27
K851506	Serum Transport Vials, T25/sc, Tz10/sc	Ncs Diagnostics, Inc.	JKA	Class II	1985-06-27
K851441	Tacticon 1600	Medecon	LRA	Unclassified	1985-06-27
K851370	Interface Transfusion Blood Filter #35	Medical, Inc.	CAK	Class II	1985-06-27
K851266	Qri-Flow Urine Flow Measuring Device	Bio-Flow, Inc.	KNX	Class II	1985-06-27
K844809	Continuous Ventilator	Hamilton Medical AG	GBX	Class I	1985-06-27
K852257	Sure-Count 15 Count Needle Counter	Kleen Test Products Corporation			1985-06-26
K852202	Strung Neuro Sponge Patties, X-Ray Opague	Ormed Mfg., Inc.	EFQ	Unclassified	1985-06-26
K852154	Ackrad Sialography Catheter	Ackrad Laboratories			1985-06-26
K852143	Hall Irrigation System	Hall Surgical, Division of Zimmer, Inc.	GBX	Class I	1985-06-26
K851633	Cc-100 Clock/calander Module Access. for G-2000 El	Eaton Medical Group	DPS	Class II	1985-06-26
K851626	Scx-35 Three Channel Access. for Module G-2000 Ele	Eaton Medical Group	DSF	Class I	1985-06-26
K851400	Sirecust 420 Patient Dialog Monitor	Siemens Medical Solutions USA, Inc.	DXJ	Class II	1985-06-26
K851044	Cardiostat 3 Recorder	Siemens Elema AB	DPS	Class II	1985-06-26
K850931	Albumin	Dilab, Inc.	CIX	Class II	1985-06-26
K850829	Wire, Guide, Catheter	Lake Region Mfg., Inc.	DQY	Class II	1985-06-26
K850828	Wire, Guide - Modification	Lake Region Mfg., Inc.	DQX	Class II	1985-06-26
K850827	Guide, Wire, Angiographic	Lake Region Mfg., Inc.	DQX	Class II	1985-06-26
K850635	Ansell No Powder Surgeon's Gloves	Ansell, Inc.	KGO	Class I	1985-06-26
K845036	Tissue Expanders for Reconstruc-Surgery 3600	Progress Mankind Technology	LCJ	Unclassified	1985-06-26
K844252	Model 9300 Trend Analyzing Bio-Monitor Sys	Medtronic, Inc.	DXN	Class II	1985-06-26
K852319	Cobas Fp Reagents for Napa and Napa Calibrators	Roche Diagnostic Systems, Inc.	LAN	Class II	1985-06-25
K852318	Cobas Fp Reagen for Primidone & Primi Calibrators	Roche Diagnostic Systems, Inc.	LFT	Class II	1985-06-25
K852317	Cobas Fp Reagen for Amikacin & Amikacin Calibrator	Roche Diagnostic Systems, Inc.	KLQ	Class II	1985-06-25
K852291	Tipsep Digoxin Ria	Nuclear Diagnostics, Inc.	DNL	Class II	1985-06-25
K852262	Assist Clinical Chemistry Analyzer	Cooper Biomedical, Inc.	JJE	Class I	1985-06-25
K852158	Bioprobe Fluor Gentamicin in Serum or Plasma	Bioprobe Intl., Inc.	LCQ	Class II	1985-06-25
K852066	Pregnancy Card Test	Em Diagnostic Systems, Inc.	JHJ	Class II	1985-06-25
K852005	Mg Reagent	Alpkem Corp.	JGJ	Class I	1985-06-25
K852002	Ca Buffer Ca Dye	Alpkem Corp.	CIC	Class II	1985-06-25
K851990	Internal Standard Solution, External Standard Solu	Alpkem Corp.	JIX	Class II	1985-06-25
K851950	Tandem E Pap	Hybritech, Inc.	JFH	Class II	1985-06-25
K851808	Electrolyte Analyzer	Ionetics, Inc.	CEM	Class II	1985-06-25
K851520	Ck/ld Isoenzymes Controls(human)	Seragen Diagnostics, Inc.	JJT	Class I	1985-06-25