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 2861 of 3529

510(k) clearances, page 2861 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864044	Esophageal/rectal Temperature Probe W/type T	Respiratory Support Products, Inc.	FLL	Class II	1986-11-04
K863996	Model Xe-103 Xenon/master II	Medi Nuclear Corp., Inc.	IYT	Class II	1986-11-04
K863958	Tubegripper, Urological Catheter & Accessory	Cathaid, Inc.	KOD	Class II	1986-11-04
K863937	Osram Ultramed 400 W	Osram GmbH	FTC	Class II	1986-11-04
K863571	Biliary Balloon Catheter	Uresil, LLC	FGE	Class II	1986-11-04
K863385	(Roth)spiral Rotating Prostatic Biopsy Needle	Cook Incorporated	KNN	Class I	1986-11-04
K863372	Sm-20 Cardioscan Doppler Option with Cfm700 Probes	Interspec, Inc.	DPT	Class II	1986-11-04
K863354	Bio-Guard Ab Coated Catheter	Cook Incorporated	KOD	Class II	1986-11-04
K863273	Martin Medical Pro-Scope Anoscope	Martin Medical	KOA	Class I	1986-11-04
K863172	Respironics Ptl Reviveeasy	Respironics, Inc.	CAO	Class II	1986-11-04
K862913	Cardioscan with Doppler Option	Interspec, Inc.	JOP	Class II	1986-11-04
K862855	Craig Naso-Gastric Tube Holder	Henley Intl.	KNT	Class II	1986-11-04
K862164	Eup-012I, Eup-012J & Eub-0124 Ultrasonic Scanner	Hitachi Medical Corp. of America	IYO	Class II	1986-11-04
K862059	Sheath, Endoscope	Endovations	FGE	Class II	1986-11-04
K855236	Diagnostic Reagent Tst-Rpla	Oxoid U.S.A., Inc.	GTN	Class I	1986-11-04
K855235	Diagnostic Reagent Pet-Rpla	Oxoid U.S.A., Inc.	JSP	Class I	1986-11-04
K855234	Diagnostic Reagent Vet-Rpla	Oxoid U.S.A., Inc.	GNA	Class I	1986-11-04
K855233	Diagnostic Reagent Set-Rpla	Oxoid U.S.A., Inc.	GTN	Class I	1986-11-04
K864181	Somatics Mouth Guard (Bite Block)	Somatics, LLC	JXL	Class II	1986-11-03
K864162	Degupal	Degussa Dental, Inc.	EJS	Class II	1986-11-03
K864141	Cordis Contrast Injection Lines	Cordis US Corp.	DQO	Class II	1986-11-03
K864117	Support Arm	Leonard Medical, Inc.			1986-11-03
K864088	Hitachi Hand Held Massager A/c Powered	Hitachi Sales Corporation of America	ISA	Class I	1986-11-03
K864048	Model 366-27 Adaptaid(tm) Step-Down Adapter	Intermedics, Inc.	DTB	Class III	1986-11-03
K864047	Model 366-28 Adaptaid(tm) Step-Down Adapter	Intermedics, Inc.	DTB	Class III	1986-11-03
K863858	Tandem-M Immunoenzymetric Assay for Ige--	Hybritech, Inc.	DGC	Class II	1986-11-03
K863781	Model 493-08 Polyflex Endocardial Lead	Intermedics, Inc.	DTB	Class III	1986-11-03
K863675	Calibration Gas for Servo Gas Monitor 120	Siemens Elema AB	BXK	Class I	1986-11-03
K863635	Updated Sterile Endotracheal Brushes	Biological & Environmental Control Laboratories	EPE	Class I	1986-11-03
K863421	Sr-Ivolen Tray Material	Ivoclar USA, Inc.	EBH	Class I	1986-11-03
K863353	Middle Ear Analyzer (Impedance Audiometer)	Grason-Stadler, Inc.	ETY	Class II	1986-11-03
K862875	E-Vac(tm)	Laerdal California, Inc.	BTA	Class II	1986-11-03
K862436	Trans- Circothyrotomy Device (Acc. Ravussin)	Acutronic Medical Systems AG	BTO	Class II	1986-11-03
K862260	Emit Chloramphenicol Assay/bi-Level Controls	Syva Co.	LCD	Class II	1986-11-03
K862190	Walrus: Double Balloon Shunting Catheter	Medical Parameters, Inc.	DWF	Class II	1986-11-03
K864100	Trycophyton Agars	BD Becton Dickinson Vacutainer Systems Preanalytic	JSH	Class I	1986-10-31
K864078	Modified N.y.c. Fermentation Medium Base	BD Becton Dickinson Vacutainer Systems Preanalytic	JTY	Class II	1986-10-31
K864077	Candida Brom Cresol Green Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	JSI	Class I	1986-10-31
K864056	Grieshaber Air System/pressure Ophthalmic Irrigant	Grieshaber & Co.	HQC	Class II	1986-10-31
K864003	Paco-Folder (Tm) Intraocular Lens Forceps	Allergan	HNR	Class I	1986-10-31
K863994	Viewscan	Sensory Aids Corp.	HOT	Class I	1986-10-31
K863993	Vts Reporter or Vts Link	Sensory Aids Corp.	HPF	Class I	1986-10-31
K863992	Thornton Titanium Forceps (Various Types)	Keeler Instruments, Inc.	HNR	Class I	1986-10-31
K863991	Thorton Titanium Needleholders(no,w Catch & Stand	Keeler Instruments, Inc.	HNR	Class I	1986-10-31
K863990	Thornton Titanium Silver Spatula	Keeler Instruments, Inc.	HND	Class I	1986-10-31
K863989	Thornton Titanium Speculum (Modified Barraquer)	Keeler Instruments, Inc.	HNC	Class I	1986-10-31
K863988	Thorton Titanium Hook Angled Right	Keeler Instruments, Inc.	HNQ	Class I	1986-10-31
K863986	Xenon Light Source for Endoscopic Procedures	American Edwards Laboratories	HRX	Class II	1986-10-31
K863728	The Ergosystem Chair	Charles D. Bell, Inc.	HME	Class I	1986-10-31
K863727	Fixation Instruments	Medical Technology Development Corp.	HNR	Class I	1986-10-31