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 2846 of 3529

510(k) clearances, page 2846 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861686	Novopen System (Insulin Syringe)	Squibb-Novo, Inc.	FMF	Class II	1987-01-21
K861628	Wellcozyme Rotavirus Wz01	Wellcome Diagnostics	LIQ	Class I	1987-01-21
K865111	Charter Hard Contact Lens Cleaning Solution	Paco Pharmaceutical Services, Inc.	HPX	Unclassified	1987-01-20
K865103	Krom-X Lens System	Neo Optics, Inc.	HQG	Class I	1987-01-20
K865097	Aimed Gauze Sponge	Kor-Medical Industries, Ltd.	EFQ	Unclassified	1987-01-20
K865095	Roll Bandage, Gauze Bandage, Various Sizes	Kor-Medical Industries, Ltd.	EFQ	Unclassified	1987-01-20
K865094	Linen (Huck) Towel	The Eye Co-Op, Inc.	KKX	Class II	1987-01-20
K864973	Tenzcare(tm) Snap Electrode 6867	3M Company	GXY	Class II	1987-01-20
K864964	5 - in - 1 Connector	Medovations, Inc.	GAZ	Class II	1987-01-20
K864923	Vacu-Prep	Diversified High Tech Co.			1987-01-20
K864899	Surgical Drape Pack	Webster Enterprises, Inc.	KKX	Class II	1987-01-20
K864810	Lidsplint	Precision Therapeutics, Inc.	HMP	Class I	1987-01-20
K864784	Seraflo(tm) Bloodlines for Hemodialysis	Cd Medical, Inc.	FJK	Class II	1987-01-20
K864753	Free Spirit(tm) i.v. Stand	Demstar Corp.	FOX	Class I	1987-01-20
K864726	I/a/kpe Tip	Ipax, Inc.	HQC	Class II	1987-01-20
K864689	Alba Health Care Iodoform Packing Strip	Alba Health Care			1987-01-20
K864594	Dualenz Low Vision Eyewear	Global Eye Care, Inc.	HKK	Class I	1987-01-20
K864520	Barron Rotary Blade Trephine Using Hessburg-Barron	Precision Instruments, Inc.	HRH	Class I	1987-01-20
K864502	The Contact Lens Assist Brush	Young and Moore Enterprises, Inc.	LPN	Class II	1987-01-20
K864453	Emergency & Military Infusion System	Simplivia Healthcare Ltd.	FPA	Class II	1987-01-20
K864441	Churchill Blood Administration Set	Churchill Corp.	BRZ	Class II	1987-01-20
K864440	Churchill 3-Way Stopcock	Churchill Corp.	FMG	Class II	1987-01-20
K864407	Refillable Syringe	Med Fusion Systems, Inc.	FMF	Class II	1987-01-20
K864402	Bipolar Electrosurgical Intraocular Probe	New England Surgical Instrument Corp.	GEI	Class II	1987-01-20
K864310	Rymco Sterile Single-Use Needle/single Use Syringe	Rymco Ltda	FMI	Class II	1987-01-20
K863886	Sportlife Sunwear	North American Vacuum Coating Co.	HQY	Class I	1987-01-20
K863694	Bed/adjust/hospital/folding Field without Mattress	Brenner Metal Prod Corp.	FNJ	Class I	1987-01-20
K863691	Cot, Folding, Hospital, Aluminum	Brenner Metal Prod Corp.	FNJ	Class I	1987-01-20
K863688	Rod, Irrigator, Supporting Telescoping, Type	Brenner Metal Prod Corp.	FNJ	Class I	1987-01-20
K863686	Back Rest, Litter, Non-Adjustable	Brenner Metal Prod Corp.	FPP	Class I	1987-01-20
K863429	Modified Device for Self Examination of Eyes	Wheel Checkers	HOQ	Class I	1987-01-20
K861267	Urocut Biopsy Needle	Meadox Surgimed, Inc.	KNW	Class II	1987-01-20
K864437	Beckman Epsilon(tm) Ferritin Test Kit	Beckman Instruments, Inc.	DBF	Class II	1987-01-16
K864393	Apolipoprotein A1 (Apo A1) Immunoturbidimetric	Intl. Diagnostic Laboratories, Ltd.	MSJ	Class I	1987-01-16
K864326	Model 366-13 Adaptaid Step Down Adapter	Intermedics, Inc.	DTB	Class III	1987-01-16
K864227	Percupump (Tm)	E-Z-EM, Inc	FRN	Class II	1987-01-16
K864000	Fst Disposable Fiber Optic Transducer #0100-00	Fiberoptic Sensor Technlogies, Inc.	DXO	Class II	1987-01-16
K863309	Refurbish Diagnostic X-Ray Equipment	Chemarts and Assoc., Inc.	KPR	Class II	1987-01-16
K863185	40Cc Percutaneous Furl Single Intra-Aortic Balloon	Aries Medical, Inc.	DSP	Class II	1987-01-16
K865093	Safe-T-Shield Mouthpiece	Medi Nuclear Corp., Inc.	BYP	Class I	1987-01-15
K865061	Shiley Dispos Cannula Fenes Lp Cuffed Trache Tube	Shiley, Inc.	BTO	Class II	1987-01-15
K865046	Salter Labs Model #4005 Gas Sampling Tee and Line	Salter Labs	BZA	Class I	1987-01-15
K864885	Spirovision	Futuremed Div. of Future Impex Corp.	BZM	Class II	1987-01-15
K864822	Varidyne 550, Models 12E,12m,24e & 24M Suction Sys	Surgidyne, Inc.	BTC	Class I	1987-01-15
K864806	Anesthesia Recorder	Draeger, Inc.	BSZ	Class II	1987-01-15
K864430	Ma-2 and Ma2+2 Volume Ventilators	Medtronic, Inc.			1987-01-15
K863953	Spirometrics Model 2500 Flowmate(tm)	Spirometrics, Inc.	BZM	Class II	1987-01-15
K863685	Cart, Orthopedic Bed, Stryker	Brenner Metal Prod Corp.	FNJ	Class I	1987-01-15
K863420	Vitalograph Ec-50 Carbon Monoxide Monitor	Vitalograph, Inc.	CCJ	Class II	1987-01-15
K863184	Profile Hip Acetabulum Prosthesis	Depuy, Inc.	JDI	Class II	1987-01-15