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 3179 of 3528

510(k) clearances, page 3179 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823535	Diluent, Zeroing Solution & Co-Ox/ise	Shaban Mfg. Co.	JKT	Class I	1983-01-28
K823504	Cyclic Adenosine Monophoshate by Radio	Immuno Nuclear Corp.	CHO	Class II	1983-01-28
K823499	Intra-Articular C02 Insufflator	Surgical Instrument Repair Service Co.	HRX	Class II	1983-01-28
K823455	Surgical Gauze	Worldwide Surgical Gauze			1983-01-28
K823382	Nephrostomy Catheter	Umi, Inc.	LJE	Unclassified	1983-01-28
K822709	Uritest 9, Inlab Reagent Strips Urinaly	Laprol Scientific, Inc.	JMA	Class I	1983-01-28
K822618	Emergency Tracheostomy Instrument Set	Kelleher Corp.	LJW	Class I	1983-01-28
K822268	Nagashima Ns-III Electronystagmograph	Kelleher Corp.	GWN	Class II	1983-01-28
K837032	Uvb Light Box Tanning Booth	Sun Shanty, Inc.			1983-01-27
K823064	Intracath-Da Intravenous Cath. Placement	Parke-Davis Co.	DQO	Class II	1983-01-27
K830057	20 Micron High Capacity Trans/filter	Travenol Laboratories, S.A.	CAK	Class II	1983-01-26
K830051	Molnlycke Mesalt Sterile Dressing	Lada Intl., Inc.	FRO	Unclassified	1983-01-26
K830042	E-Z Jector	Innovators, Inc.	EJI	Class II	1983-01-26
K830038	Sigma 7000-6000 Infusion Pumps	Sigma	FRN	Class II	1983-01-26
K830018	Safe-T Arm Board	Harvey A. Turner, M.D.	BTX	Class I	1983-01-26
K830017	Volumetric Pump Admin. Sets	Travenol Laboratories, S.A.	FRN	Class II	1983-01-26
K830010	Superjet Lancet	Medprobe Laboratories	FMK	Class II	1983-01-26
K830008	Karickhoff Keratoscope	Surgidev Corp.	HLR	Class I	1983-01-26
K823928	Tooth Conditioner	Dentsply Intl.	DYH	Class II	1983-01-26
K823913	Soft Grip Uni-Handle	Treace Medical, Inc.	EJB	Class I	1983-01-26
K823857	Impra Peritoneal Catheter	Impra, Inc.	FKX	Class II	1983-01-26
K823795	Everbond Glass Ionomer Cement	Sybron Corp.	EMA	Class II	1983-01-26
K823755	Biceps Electrocautery System	Squibb Diagnostics	HAM	Class II	1983-01-26
K823696	Micro Z Blood Collecting Needles	Hospital Products Co.	FMI	Class II	1983-01-26
K823538	Pour Bottle Decanter #2010	Medi-Plant Intl.	KPE	Class II	1983-01-26
K823390	Pc 201A Locking Sleeve	Medigroup	FKX	Class II	1983-01-26
K823331	Pc-204 Tunnelor	Medigroup	FKX	Class II	1983-01-26
K823330	Dialators Pc-203 & 202	Medigroup	FKX	Class II	1983-01-26
K823303	Quill Catheter Guide	Medigroup	FKX	Class II	1983-01-26
K823296	Pc-205 Tenckhoff Catheter Rod Obturator	Medigroup	FKX	Class II	1983-01-26
K823268	Model 78670A	Hewlett-Packard Co.	LDD	Class II	1983-01-26
K823188	M2000 Intrapartum Fetal Monitor	Huntleigh Technology, Inc.	HGM	Class II	1983-01-26
K823081	M2100 Antepartum Fetal Monitor	Huntleigh Technology, Inc.	HGM	Class II	1983-01-26
K823068	Medisystems Fistula Needles	Medisystems Corp.	KOC	Class II	1983-01-26
K823018	Model 460 Intermittent Medication Deliv	Y	FLN	Class II	1983-01-26
K820038	Sigma 7000	Sigma	FRN	Class II	1983-01-26
K837030	Model Ml-4000 Ophthalmic Laser with Fiber Optic Delivery System	Meditec Co., Ltd.			1983-01-24
K830088	Traction 230	Tri W-G, Inc.	ITH	Class II	1983-01-24
K830012	Medela Suction Pump	Medela AG	HDB	Class II	1983-01-24
K827577	Variable Contrast Acuiometer, Diagnostic Laser Interferometer	Randwal Instrument Co., Inc.			1983-01-24
K823846	Uric Acid Test	Scalavo, Inc.	KNK	Class I	1983-01-24
K823840	Medela Namual Breast Pump	Medela AG	HGY	Class I	1983-01-24
K823753	Genesis B-Hcg	Armkel, LLC	JHI	Class II	1983-01-24
K823405	Zimmer Great Toe	Zimmer GmbH	KWH	Class II	1983-01-24
K823342	Percor Intra-Aortic Balloon Insertion	Datascope Corp.	DSP	Class II	1983-01-24
K830145	Panty-Liners Unscented	Procter & Gamble Mfg. Co.	HHD	Class I	1983-01-21
K830144	Panty-Liners Scented	Procter & Gamble Mfg. Co.	HHL	Class II	1983-01-21
K830028	Sirecust 456	Analogic Corp.	DXH	Class II	1983-01-21
K830022	S.m.p. Contrast Media Set	Omega Technologies, Inc.	DQO	Class II	1983-01-21
K823916	Wax Curette Tip	Treace Medical, Inc.	JYG	Class I	1983-01-21