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 1840 of 3531

510(k) clearances, page 1840 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974496	A-2000 EEG Monitor with Bis	Aspect Medical Systems, Inc.	OLW	Class II	1998-02-06
K974448	Cordis Brite Tip Catheter Sheath Introducer System	Cordis US Corp.	DYB	Class II	1998-02-06
K974331	Uni-Rom Total Hip System Femoral Stem	Johnson & Johnson Professionals, Inc.	LPH	Class II	1998-02-06
K974310	Nomos Slit Collimator (Beak)	Nomos Corp.	IYE	Class II	1998-02-06
K974301	Clk Int'l. Sanitary Latex Probe Cover, Clk Ultrasound Probe Cover	Clk Intl., Inc.	ITX	Class II	1998-02-06
K974209	Silicone Tissue/inflatable Tissue Expander	Specialty Surgical Products, Inc.	LCJ	Unclassified	1998-02-06
K974205	Knitted Wound Dressing-Standard, Wcl and Ribbon	Convatec, A Division of E.R. Squibb & Sons	KMF	Class I	1998-02-06
K974199	Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) Option	Marquette Medical Systems, Inc.	LOS		1998-02-06
K974101	Datex-Engstrom Network	Datex-Engstrom, Inc.	MSX	Class II	1998-02-06
K973949	Perioperative Data Management System	Draeger, Inc.	BSZ	Class II	1998-02-06
K973669	Thrombolytic Brush Catheter, Over the Wire (Otw)	Medtronic, Inc.	MCW	Class II	1998-02-06
K972959	Amplaid Mk22	Amplifon	GWF	Class II	1998-02-06
K972906	Medtronic Twist Lock Anchor (Partnumber 103953/3550Tla)	Medtronic, Inc.	GZB	Class II	1998-02-06
K972740	Himex Centriflow Centrifugal Perfusion Pump System (Cfk01)	Himex Production Corp.	KFM	Class II	1998-02-06
K972326	Peba Anchor/suture Combination	Orthopaedic Biosystems, Ltd.	MBI	Class II	1998-02-06
K971799	Precision Flow Osv II	Elekta Implants, SA	JXG	Class II	1998-02-06
K980098	Vacutainer Brand Pronto Needles Holder	Becton Dickinson Vacutainer Systems	JKA	Class II	1998-02-05
K980057	Careside Bun	Exigent Diagnostics, Inc.	CDQ	Class II	1998-02-05
K974873	Vacuette (Multi-Use Holder)	Greiner Meditech, Inc.	JKA	Class II	1998-02-05
K974810	Accurun(tm) 132 Borrelia Burdorferi Igm Positive Control	Boston Biomedica, Inc.	LSR	Class II	1998-02-05
K974809	Accurun(tm) 130 Borrelia Burgdorferi Igg Positive Control	Boston Biomedica, Inc.	LSR	Class II	1998-02-05
K974616	Singer Acupuncture Needles	Lorac, Inc.	MQX	Class II	1998-02-05
K974526	Easyblood Gas Analyzer	Medica Corp.	CHL	Class II	1998-02-05
K974372	Air Oxyge Mixer	Sk Med	BZR	Class II	1998-02-05
K973734	Sterile Water for Device Irrigation/ Sterile Saline for Device Irrigation	Welcon, Inc.	JOL	Class II	1998-02-05
K973590	Hemorrelief Device	A.Stein - Regulatory Affairs Consulting	LKX	Unclassified	1998-02-05
K973336	Imex Stethodop	Imex Medical Systems, Inc.	JAF	Class II	1998-02-05
K973235	Dyract Ap Restorative	Dentsply Intl.	EBF	Class II	1998-02-05
K972990	Magnetic Resonance Diagnostic System	GE Healthcare	LNH	Class II	1998-02-05
K980088	T-Uptake Microplate Eia	Monobind, Inc.	KHQ	Class II	1998-02-04
K980042	Careside Total Protein	Exigent Diagnostics, Inc.	CEK	Class II	1998-02-04
K980041	Careside Albumin	Exigent Diagnostics, Inc.	CIX	Class II	1998-02-04
K980013	Amylase	Ac Biochemicals, Inc.	CIJ	Class II	1998-02-04
K974839	Alpha Dx Analyzer 01-0100, Alpha Dx Myo/ck/ck-Mb/tni Cardiac Panel Test Kit 03-0001, Alpha Dx Ck/ck-Mb Panel Test Kit	First Medical, Inc.	MMI	Class II	1998-02-04
K974635	Paragon Lens Care	Paragon Vision Sciences, Inc.	LRX	Class II	1998-02-04
K974582	Quickscreen One Step Pcp Screening Test	Phamatech Inc.	LCM	Unclassified	1998-02-04
K974390	Gluma One Bond	Kulzer GmbH	KLE	Class II	1998-02-04
K974238	Dental Tray, Sterile, Disposable	Trinity Laboratories, Inc.	EIA	Class I	1998-02-04
K974213	Aurora Titanium Spinal Rod System	United States Surgical, A Division of Tyco Healthc	MNH	Class II	1998-02-04
K974203	Perry-Kolberg (Pk) Titanium Motility/support System	Integrated Orbital Implants Inc	MQU	Class II	1998-02-04
K974195	Flexible Tip Digital Thermometer	K-Jump Health Co., Ltd.	FLL	Class II	1998-02-04
K973996	Clearline Plus, Dental Waterline Filter	Scitech Solutions, Inc.	EIA	Class I	1998-02-04
K973938	Alpha 4 Ls Automated Microtiterplate Processor and Reader	Sfri, Inc.	JJQ	Class I	1998-02-04
K980196	Md Tech Biopsy Set for Bone and Bone Marrow	Medical Device Technologies, Inc.	KNW	Class II	1998-02-03
K974553	3M Universal Electrosurgical Pad, Split (9160) 3M Universal Electrosurgical Pad (9130)	3M Healthcare	GEI	Class II	1998-02-03
K974320	Cryogen Cardiac Cryosurgical System	Cryogen, Inc.	OCL	Class II	1998-02-03
K974233	Lysonix Irrigation System	Lysonix, Inc.	GBX	Class I	1998-02-03
K974208	Tytron C-3000	Titronics Research & Development	HCS	Class II	1998-02-03
K973596	Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module	GE Healthcare	OLW	Class II	1998-02-03
K973172	Resposable Bare Fibers	Trimedyne, Inc.	GEX	Class II	1998-02-03