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 2754 of 3530

510(k) clearances, page 2754 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K875101	Virogen Cmv Antibody Test	Wampole Laboratories	LQO	Class I	1988-03-01
K874694	Adap-Temp, Model: at-100	Respiratory Support Products, Inc.	FLL	Class II	1988-03-01
K874620	Gen-Probe Pace System for Neisseria Gonorrhoeae	Hologic, Inc.	LSL	Class II	1988-03-01
K873159	Combison(r) 310A Real Time Ultrasound Scanner	Cone Instruments, Inc.	IYO	Class II	1988-03-01
K870816	Kontron Stressdata Stress Data Management System	Kontron Instruments, Inc.	DSI	Class II	1988-03-01
K880553	Electronic Epilator	Clareblend, Inc.	KCW	Class I	1988-02-29
K880528	Overhead Tube Mount Cascade II	Fischer Imaging Corp.	IYB	Class I	1988-02-29
K880527	Ceiling Mounted Fluoroscopic C-Arm Ariel C-Arm	Fischer Imaging Corp.	JAA	Class II	1988-02-29
K880411	Dey-Vial Sodium Chloride Solution, Usp, Sterile	Dey Laboratories, Inc.	CAF	Class II	1988-02-29
K880394	First Response Pediatric Emergency Resuscitator	Intertech/Ohio	BTM	Class II	1988-02-29
K880317	Prefilled Sodium Chloride Solution for Irriga. Usp	Automatic Liquid Packaging, Inc.	BTO	Class II	1988-02-29
K880316	Prefilled Water for Irrigation Usp	Automatic Liquid Packaging, Inc.	BTO	Class II	1988-02-29
K880309	Type 316L Stainless Steel Wire	Winn Hirsch & Assoc.	JDQ	Class II	1988-02-29
K880272	Cal/rad Upgrade Model 1030	Sun Nuclear Corporation	KPT	Class II	1988-02-29
K880101	Liberator 53/Stroller 50	Minnesota Valley Engineering, Inc.	BYJ	Class II	1988-02-29
K880094	Van-Tec Endopyelotomy Knife	Van-Tec, Inc.	EMF	Class I	1988-02-29
K880050	Edec 60R	Electromed Intl., Ltd.	IZO	Class I	1988-02-29
K875352	Hi Flow Portable Liquid Oxygen Unit	Minnesota Valley Engineering, Inc.	BYJ	Class II	1988-02-29
K875265	Non-Invasive Blood Pressure Module	Ppg Industries, Inc.	DXN	Class II	1988-02-29
K875142	Phase II	Reliance Orthodontic Products, Inc.	DYH	Class II	1988-02-29
K875117	Ciba Corning Balanced Heparin for Ca++	Ciba Corning Diagnostics Corp.	CBT	Class I	1988-02-29
K875095	Pall Cardioplegia Plus Filter W/posidyne Membrane	Pall Biomedical Products Co.	JOD	Class II	1988-02-29
K875094	Ultipor Pre-Bypass Plus Filter W/posidyne Membrane	Pall Biomedical Products Co.	KRJ	Class II	1988-02-29
K875091	Oralin Tlc Light Cured Pit and Fissure Sealant	Mission White Dental, Inc.	EBC	Class II	1988-02-29
K875090	Auto Suture Disposable Approximating Clamp*	United States Surgical, A Division of Tyco Healthc	DXC	Class II	1988-02-29
K875080	Air Vent Line Cat. No. Avl-36	American Omni Medical, Inc.	DTM	Class II	1988-02-29
K875073	Breathe-Free	Cincinnati Medical Technologies, Inc.	BYE	Class II	1988-02-29
K875064	Scimed Inflation Device, Model Sm 2000	Scimed Life Systems, Inc.	LIT	Class II	1988-02-29
K875016	Biosurge Model Ilvc-1	Biosurge, Inc.	DWS	Class I	1988-02-29
K874733	Guardian, EEG Brain Monitoring System	Tracor Northern, Inc.	OLT	Class II	1988-02-29
K874567	Resuscitator	American Medical Technology, Inc.	BTM	Class II	1988-02-29
K874450	Schachner-Ovil Rapitrac Percutan. Tracheostomy Kit	Surgitech C/O Collier, Shannon, Rill & Scott	BTO	Class II	1988-02-29
K874047	Asthmakit	Dhd Medical Products Div. Diemolding Corp.	CAF	Class II	1988-02-29
K873526	Pall Field Medical Oxygen Genera. & Distri. System	Pall Safety Atmospheres, Inc.	CAW	Class II	1988-02-29
K873100	Olympus Angioscopy Sheath	Olympus Corp.	DYB	Class II	1988-02-29
K872573	Pharmaclusive (Tm)	Pharmacia, Inc.	NAD	Class I	1988-02-29
K880706	Surgical Burs	Nuell Air Equipment & Hospital Supplies, Inc.	GFF	Class I	1988-02-26
K880686	Toronto/mobilimb Hand C.p.m.	Toronto Medical Corp.	JFA	Class I	1988-02-26
K880299	Replicare	United Medical Inc	FRO	Unclassified	1988-02-26
K880284	Addvantage:tvc Marcon	Richards Medical Co., Inc.	ESD	Class I	1988-02-26
K880202	Okamoto Condoms	Schmid Laboratories, Inc.	HIS	Class II	1988-02-26
K880018	Lido(tm) Workset	Loredan Biomedical, Inc.	IKK	Class II	1988-02-26
K880017	Lido(tm) Lift	Loredan Biomedical, Inc.	IKK	Class II	1988-02-26
K875331	Biconcave Vitrectomy Lens	Ocular Instruments, Inc.	HJK	Class II	1988-02-26
K875330	Hoskins-Barkan Goniotomy Lens 10Mm	Ocular Instruments, Inc.	HJK	Class II	1988-02-26
K875308	Professional Series Biofeedback Devices Model 421	Self Regulation Systems, Inc.	HCC	Class II	1988-02-26
K875256	Biscolor	Bisco, Inc.	EBF	Class II	1988-02-26
K875243	Db Precision Implant System, 2000 Series W/hac	Driskell Bioengineering	DZE	Class II	1988-02-26
K875242	Db Precision Implant System, 1000 Series W/hac	Driskell Bioengineering	DZE	Class II	1988-02-26
K875145	Mar Bond	Reliance Orthodontic Products, Inc.	EBG	Class II	1988-02-26