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 2005 of 3531

510(k) clearances, page 2005 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K954351	Series 50Xm	Hewlett-Packard Co.	HGM	Class II	1996-03-08
K953806	Synthes (USA) Midfacial System	Synthes (USA) Products LLC	JEY	Class II	1996-03-08
K953777	Synthes Wire Mount	Synthes (USA) Products LLC	JDQ	Class II	1996-03-08
K953644	Volar Distal Radius Plate	Synthes (USA) Products LLC	HRS	Class II	1996-03-08
K953607	Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-Dhs)	Synthes (USA) Products LLC	JDO	Class II	1996-03-08
K945518	P.f.c. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Professionals, Inc.	KWY	Class II	1996-03-08
K932330	Ti-6Al-7Nb Urtn	Synthes (USA) Products LLC	HSB	Class II	1996-03-08
K960473	Aesculap Power System Handpiece	Aesculap Inc	GET	Class I	1996-03-07
K960326	Fcr Dms Optical Disk Image Filing Unit Od-F614, Odf614l & Multimodality System	FUJIFILM Healthcare Americas Corporation	LMB	Class I	1996-03-07
K960284	Oticon /Primofocus (Pf)	Oticon, Inc.	ESD	Class I	1996-03-07
K960229	Resound Real Ear Loudness Mapping (Relm) System	Resound Corp.	ETW	Class II	1996-03-07
K960155	Unitron Model Sound F/xp	Unitron Industries, Inc.	ESD	Class I	1996-03-07
K960031	Audioflex 120	Maico Hearing Instruments, Inc.	ESD	Class I	1996-03-07
K955588	Vascutek Graft Sizer Set	Carbomedics, Inc.	DSY	Class II	1996-03-07
K955262	Truzone Peak Flow Meter	Monaghan Medical Corp.	BZH	Class II	1996-03-07
K955050	Jetstream Cavity Preparation System	Dove Systems, Inc.	KOJ	Class II	1996-03-07
K955025	Axsym Progesterone	Abbott Medical	JLS	Class I	1996-03-07
K954938	Disposable Neuroview Operating Sheath	Neuro Navigational Corp.	GWG	Class II	1996-03-07
K954704	Vs-200 Video Sigmoidoscope	Welch Allyn Inc	FDF	Class II	1996-03-07
K954394	Aesculap Ventriculoscope System	Aesculap Inc	GWG	Class II	1996-03-07
K953821	Biocor 200 Hardshell Venous Reservior	Medivators Inc	DTN	Class II	1996-03-07
K953391	Treatment Management System	Siemens Medical Solutions USA, Inc.	LHN	Class II	1996-03-07
K950943	Ultra Ease	Lectec Corp.	IYO	Class II	1996-03-07
K960551	Dsl Active Human Growth Hormone Elisa	Diagnostic Systems Laboratories, Inc.	CFL	Class I	1996-03-06
K960550	Active T3 Ria	Diagnostic Systems Laboratories, Inc.	CDP	Class II	1996-03-06
K960465	Sas Salmonella O Group P Factor 38 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960463	Sas Salmonella O Group U Factor 43 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960462	Sas Salmonella O Group Q Factor 39 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960460	Sas Salmonella O Factor 46 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960459	Sas Salmonella O Group S Factor 41 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960458	Sas Salmonella O Group T Factor 42 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960163	Sas Salmonella 0 Factor Factor 5 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960162	Sas Salmonella 0 Group 0 Factor 35 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960161	Sas Salmonella 0 Group N Factor 30 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960153	Sas Salomnella 0 Group L Factor 21 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960152	Sas Salmonella 0 Factor 12 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960150	Sas Salmonella 0 Group J Factor 17 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960149	Sas Salmonella 0 Group F Factor 11 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960145	Sas Salmonella 0 Factor 27 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960142	Sas Salmonella 0 Factor 23 Antiserum And/or Sas Slamonella 0 Group G2 Factor 23 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960140	Sas Salmonella 0 Factor Antiserum And/or Sas Salmonella 0 Group C1 Factor 7 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960138	Sas Salmonella 0 Factor 8 Antiserum And/or Sas Salmonella 0 Group C2 Factor 9 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960137	Sas Salmonella H Z10 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960136	Sas Salmonella H P Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960135	Sas Salmonella H M Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960134	Sas Salmonella 0 Factor 9 Antiserum And/or Sas Salmonella 0 Group D Factor 9 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960132	Sas Salmonella H U Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960127	Sas Salmonella O Factor 22 Antiserum &/or Sas Salmonella O Group G1 Factor 22 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960126	Sas Salmonella O Factor 19 Antiserum &/or Sas Salmonella O Group E4 Factor 19 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960125	Sas Salmonella O Factor 4 Antiserum &/or Sas Salmonella O Group B Factor 4,5 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06