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 2026-10-26, 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 2756 of 3530

510(k) clearances, page 2756 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K875132	Periodontal Scaling Solution-a	Dentsply Intl.	EFS	Class I	1988-02-23
K875010	In-the-Ear Hearing Aid	Statco Hearing Aid Laboratory	ESD	Class I	1988-02-23
K874510	Rionet Hearing Aid Hb-75	Rion Acoustic Instruments, Inc.	ESD	Class I	1988-02-23
K880583	Modified Formed-Extension Mahurkar Dual Lumen Cath	Quinton, Inc.	MPB	Class II	1988-02-22
K880486	Dermgard System 800 and 900	Dermgard, Inc.	IOQ	Class II	1988-02-22
K880432	Vicor Pacer, Model 410A	Tpl-Cordis, Inc.	DXY	Class III	1988-02-22
K875106	Pb-a Lead-Acid Battery Conversion Kit	Diagnostic Imaging Specialists Corp.	IZL	Class II	1988-02-22
K875078	Heracure Ls 500	W.C. Heraeus GmbH	HHR	Class II	1988-02-22
K875074	Vacumate Intermittent/continuous Controller,vm2000	Timeter Instrument Corp.	KDP	Class II	1988-02-22
K875063	Seiko Plax Diacoat II & Seiko Plax S.v.p.	Epson el Paso, Inc.	HQG	Class I	1988-02-22
K874877	Pegasus Airwave Syst/spec Mattress Decubitus Ulcer	Pegasus Airwave, Inc.	FNM	Class II	1988-02-22
K874831	Audiotone Model A2000 Behind-the-Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1988-02-22
K874480	Modified Manufacturing Process for Omiderm(tm)	Omikron Scientific, Ltd.	NAD	Class I	1988-02-22
K874313	Model 492 Ssr (Tm) Recorder	Del Mar Avionics	DSH	Class II	1988-02-22
K874214	S9 Display System	O.M.I. Oncology Microsystems, Inc.	JAD	Class II	1988-02-22
K874181	Baxter Bedside System	Travenol Laboratories, S.A.	FRN	Class II	1988-02-22
K872926	Dermatological Patch	Convatec, A Division of E.R. Squibb & Sons	FRO	Unclassified	1988-02-22
K872525	A.l.a.r.m. (Adjust. Leg & Ankle Repositioning Mech	M.C. Johnson Co., Inc.	KPR	Class II	1988-02-22
K872369	Loma Linda Univ. Proton Beam Therapy System	Loma Linda University Medical Center	IWM	Class II	1988-02-22
K871572	Rhythmscan	Brentwood Instruments, Inc.	DSI	Class II	1988-02-22
K880538	Track and Carrier, Intravenous	Ferguson Medical	FOX	Class I	1988-02-19
K880385	Kimberly-Clark Professional Jacket	Kimberly-Clark Corporation	FME	Class I	1988-02-19
K880327	Marlen Ultra Ileostomy Pouch-5000	Marlen Mfg. & Development Co.	EZQ	Class I	1988-02-19
K880302	Calcium Chloride Solution 0.1M, in Hepes Buffer	Hemotec, Inc.	GGN	Class II	1988-02-19
K880297	Sea - Port Infusion Set	Harbor Medical Devices, Inc.	LJT	Class II	1988-02-19
K880292	Factor VIII Reference Plasma	Helena Laboratories, Corp.	GJT	Class II	1988-02-19
K880084	Gf 120M, 120H, 180M & 180H Hollow Fiber Dialyzers	Gambro, Inc.	FJI	Class II	1988-02-19
K875312	Ufr Digital Retrofit	Yankee Intl. Medical Research & Mfg., Ltd.	FJB	Class II	1988-02-19
K875214	A Port Implantable Vascular Access System	Therex Corp.	LJT	Class II	1988-02-19
K875124	Low-Power Binocular Loupe	Seiler Instrument & Mfg. Co.,Inc.	HOH	Class I	1988-02-19
K875121	Amicon Equaline Fluid Balance System	Amicon, Inc.	KPF	Class II	1988-02-19
K875114	Hoskins-Barkan Goniotomy Lens 9Mm	Ocular Instruments, Inc.	HJK	Class II	1988-02-19
K875087	Peyman G. 12.12 Yag Laser Lens	Ocular Instruments, Inc.	HJK	Class II	1988-02-19
K875033	Sterile Scrubby Scrub Brush	Medsurg Industries, Inc.	GEC	Class I	1988-02-19
K874945	Cement Liner	Dentsply Intl.	EMA	Class II	1988-02-19
K874922	Acuson Transperineal Needle Guide	Acuson Computed Sonography	ITX	Class II	1988-02-19
K874872	Fresenius Hemoflow F3, F4, F5, F7	Seratronics, Inc.	FJI	Class II	1988-02-19
K874858	Lasertripter Miniscope	Candela Corporation	ODF	Class II	1988-02-19
K874838	Coulter Counter Model T Series W/2-Part Different.	Coulter Electronics, Inc.	GKZ	Class II	1988-02-19
K874761	Rapid Colorimetric Direct Strep a Test	New Horizons Diagnostics Co.	GTZ	Class I	1988-02-19
K874748	Immpulse Digoxin Assay Reagents	Sclavo, Inc.	LCS	Class II	1988-02-19
K874722	Hollywoods Cool Shades	Tonka Corp.	HQY	Class I	1988-02-19
K874602	Asd-Bio Anti-Stick Device	Biosurge, Inc.	FMI	Class II	1988-02-19
K873926	Storz Contoured Anatomical Plating Instrument	Storz Instrument Co.	JEY	Class II	1988-02-19
K872441	High Freq Linear Array(hfla)scanhead W/dplr Sidear	Advanced Technology Laboratories, Inc.	DPT	Class II	1988-02-19
K880441	Pediatric Airway Measurement System & P.a.m.s.	Plane Iii, Inc.	FTY	Class I	1988-02-18
K880436	Microtrak Hsv Culture Identification Test	Syva Co.	GQN	Class II	1988-02-18
K880405	Silastic Nasal Implant S-Type	Dow Corning Wright	FZE	Class II	1988-02-18
K880331	Hook Punch Forceps for Arthroscopy	Kibbutz Gilgal Medical C/O Toam U.S.A. Corp.	HRX	Class II	1988-02-18
K880282	Lima-Lto. Sem Modular External Stablizer	Lima-Lto S.p.A.	JEC	Class II	1988-02-18