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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2637 of 3530

510(k) clearances, page 2637 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K893429	Alpha Condor	Alpha Unlimited, Inc.	INI	Class II	1989-06-12
K893428	Alpha Shopper	Alpha Unlimited, Inc.	ITI	Class II	1989-06-12
K893227	Argenco W+	Argen Precious Metals, Inc.	EJT	Class II	1989-06-12
K893037	No-Mix 30 Orthodontic Bonding Systems	American Orthodontics	DYH	Class II	1989-06-12
K893035	Ophthascan 'S' Mini-a	Biophysic Medical, Inc.	IYO	Class II	1989-06-12
K892811	Argelite 54B	Argen Precious Metals, Inc.	EJT	Class II	1989-06-12
K892704	Gem II Orthodontic Bracket	Ormco Corp.	EJF	Class I	1989-06-12
K892529	Repro-Med Neonate Aspiration System	Repro-Med Systems, Inc.	BSY	Class I	1989-06-12
K892435	Kendall Curity Oxygen Nasal Cannula	The Kendal Co.	CAT	Class I	1989-06-12
K892432	Kendall Curity Endotracheal Tubes	The Kendal Co.	BTR	Class II	1989-06-12
K892373	Dental Plastic Bite Fork	Texapol Corp.	EJP	Class I	1989-06-12
K892207	Franz(tm) Moveable Stylet Map Catheter, Modified	Ep Technologies, Inc.	DRF	Class II	1989-06-12
K892002	Neochrome(r) III Glucose	American Monitor Corp.	CGA	Class II	1989-06-12
K891612	Drilling Machine W/handpieces & Internal Irriga.	Implant Innovations International, Inc.	EFD	Class I	1989-06-12
K891611	Models 6526,6527,6528 Percu. Trans. Angio. Cath.	Medtronic Versaflex, Inc.	LJT	Class II	1989-06-12
K891595	Model 116 Fetal Monitor	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1989-06-12
K891408	Modified Profile Hip Acetabular Prosthesis	Depuy, Inc.	JDX	Class II	1989-06-12
K890932	Cav 3.0C Software Program	Siemens Life Support Systems	BZK	Class II	1989-06-12
K890800	Rotating Hemostatic Valve	Datascope Corp.	LIT	Class II	1989-06-12
K890637	Extended Obstetrics Software Computation Package	Elscint, Inc.	HEM	Class II	1989-06-12
K890355	Dental X-Ray Bite Block	Bite-A-Block	EGZ	Class I	1989-06-12
K890198	Paramed Model 9350 Blood Pressure Monitor (9350)	Paramed Technology, Inc.	DXN	Class II	1989-06-12
K890072	Primrose Female Ext. Cath or Ext. Urinary Drainage	Medireach, Inc.	KNY	Class II	1989-06-12
K890010	Cm 7000Mr	Trudell Medical	CAP	Class II	1989-06-12
K884910	Model 1010, Cy-Met	Cybermedic, Inc.	BZK	Class II	1989-06-12
K884793	Advent Ventilator	GE Healthcare	CBK	Class II	1989-06-12
K884250	Radovan Tissue Expander (Option Integral Inject.)	Mentor	LCJ	Unclassified	1989-06-12
K881979	Resubmittal of Mi 1000C Microimager	Ausonics Pty, Ltd.	JOP	Class II	1989-06-12
K893473	Communi-Call	Carepartners, Inc.	ILQ	Class II	1989-06-09
K893448	Tru Trac Traction Table	Tru-Trac	ITH	Class II	1989-06-09
K893223	Rep Lipo-8 Kit, No. 3182/Rep Lipo-16 Kit, No. 3181	Helena Laboratories, Corp.	JHO	Class I	1989-06-09
K893149	Plymouth & Lawana Exam Gloves	Healthgard Medical Products Ltd. Partnership	LYY	Class I	1989-06-09
K893056	Patient Examination Gloves	Hope Rubber Industrial Corp.	LYY	Class I	1989-06-09
K892741	Patient Examination Gloves (Latex)	Dmacs Intl. Corp.	LYY	Class I	1989-06-09
K892706	Sr1 (Fsh) Immunoenzymetric Assay	Serono-Baker Diagnostics, Inc.	CGJ	Class I	1989-06-09
K892424	Rep Spe Hi-Res System No. 3176, 3177, 3178	Helena Laboratories, Corp.	CFF	Class II	1989-06-09
K892288	Patient Examination Gloves (Latex)	Ansell, Inc.	LYY	Class I	1989-06-09
K892212	Innofluor(tm) Quindine Calibator Set	Innotron of Oregon, Inc.	DLJ	Class II	1989-06-09
K892208	Innofluor(tm) Quinidine Reagent Set	Innotron of Oregon, Inc.	LBZ	Class II	1989-06-09
K891991	Bicarbonate; System Pack Reagents	Boehringer Mannheim Corp.	KHS	Class II	1989-06-09
K891880	Patient Examination Gloves (Latex)	Jextrag Schaffhausen AG	LYY	Class I	1989-06-09
K891698	Zarolan, Dualan, Titan and Superon	Dent Zar, Inc.	EBF	Class II	1989-06-09
K891593	Listeria Selective Enrichment Medium	Oxoid U.S.A., Inc.	JSI	Class I	1989-06-09
K891583	Ivac Variable Pressure Volumetric Pump, 570 Series	Y	FRN	Class II	1989-06-09
K891574	Lithium Concentrate #Sr1031, Na/k Standards Sr1030	Em Diagnostic Systems, Inc.	JGT	Class II	1989-06-09
K891544	Dialbumin	Exocell, Inc.	JIR	Class I	1989-06-09
K891536	Enamel Microabrasion Compound	Premier Dental Products Co	EJR	Class I	1989-06-09
K891477	Clirans Hollow Fiber Hemodialyzer (Wet)	Terumo Medical Corp.	FJI	Class II	1989-06-09
K891288	Tegasorb(tm) Ulcer Dressing, #90-Xxx	3M Company	FRO	Unclassified	1989-06-09
K891083	Ceramic Total Hip Ball Head, Small Taper	Depuy, Inc.	LZO	Class II	1989-06-09