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 2725 of 3530

510(k) clearances, page 2725 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881382	Xomed Audiant Bone Conductor	Xomed, Inc.	LXB	Class II	1988-06-21
K880820	Okamoto Condoms Spermicidally Lubricated	Schmid Laboratories, Inc.	HIS	Class II	1988-06-21
K875123	Orcepad	Alton Dean Medical, Inc.	HDD	Class II	1988-06-21
K874028	Acuson S328 Transducer	Acuson Computed Sonography	IYO	Class II	1988-06-21
K873396	Kontron Capnograph Monitor, Supermon Module 7281	Kontron Instruments, Inc.	CCK	Class II	1988-06-21
K872048	Transonic Flowmeter	Transonic Systems Inc	DPW	Class II	1988-06-21
K882291	Retrofit Baby Face Shield (Rfs)	Physician Engineered Products, Inc.	LBI	Class II	1988-06-20
K882242	Landmark(tm) Venous Access Device	Menlo Care, Inc.	FOZ	Class II	1988-06-20
K882163	Helena Rep Gel Processor	Helena Laboratories, Corp.	JJN	Class I	1988-06-20
K882121	C-Flo Suction Tube	Concept, Inc.	DXQ	Class II	1988-06-20
K882037	Sharplan Medilas 4060 N	Sharplan Lasers, Inc.	GEX	Class II	1988-06-20
K882007	Extended Life Injection Site	Baxter Healthcare Corporation	FPA	Class II	1988-06-20
K881991	Lyphochek Urine Toxicology Control - Negative	Bio-Rad	DIF	Class I	1988-06-20
K881990	Lyphochek Urine Toxicology Control - Low	Bio-Rad	DIF	Class I	1988-06-20
K881989	Lyphochek Urine Toxicology Control	Bio-Rad	DIF	Class I	1988-06-20
K881763	Colorado Needle Electrode	Colorado Biomedical, Inc.	JOS	Class II	1988-06-20
K881687	Cavitron Electrosurgical Module (Cem) and Pak	Cavitron Surgical Systems	GEI	Class II	1988-06-20
K881158	Vascular Clamp	T. Korossurgical Instruments Corp.	DXC	Class II	1988-06-20
K881116	Easy-Test Emit(r) Lidocaine Lido Item No. 16641	Diagnostic Systems	KLR	Class II	1988-06-20
K881036	Hemo Suc Number Hs100-Hs205	Instrumental Medico Croquevielle S.A.	GCY	Class I	1988-06-20
K880733	Bard Pca II Infusion Pump	C.R. Bard Inc	FRN	Class II	1988-06-20
K880570	Denver Pleuro-Peritoneal Shunt	Cerenovus, Inc.	KPM	Class II	1988-06-20
K880145	Lyphochek Therapeutic Drug Monitoring Control	Bio-Rad	DIF	Class I	1988-06-20
K880061	Fuller Irflex Fiber Optic Surgical Laser System	Abbott Medical	GEX	Class II	1988-06-20
K882297	1/2 Cm Rear Tip Extender (Rte)	American Medical Systems, Inc.	FHN	Class II	1988-06-17
K882203	Neotech Universal Adapter	Neotech Products, LLC	BZA	Class I	1988-06-17
K882170	Rx Aspen	Jeneric/Pentron, Inc.	EJH	Class II	1988-06-17
K882169	Surgical Duct Clamp (Vine)	Henley Intl.	GDJ	Class I	1988-06-17
K882077	Microdiscectomy Currettes	Karlin Technology, Inc.	LXH	Class I	1988-06-17
K882072	Orthopaedic and Spinal Ring Currettes	Karlin Technology, Inc.	JXH	Class II	1988-06-17
K882069	Spinal Distractors, Spanners	Karlin Technology, Inc.	LXH	Class I	1988-06-17
K882062	Model Biostar	Targus Concepts	HCC	Class II	1988-06-17
K881378	Pfizer Hospital Products Group Acl Drill Guide	Pfizer Inc	LXI	Class I	1988-06-17
K881252	Pleur-Evac(r) A6000 Adult/pediatric Chest Drainage	Deknatel, Inc.	GCX	Class II	1988-06-17
K880504	Mct Medical Browne Uroscan Urodynamic	Mct Medical, Inc.	EXY	Class II	1988-06-17
K880503	Mdl-1 Lasertripter	Candela Corporation	FFK	Class II	1988-06-17
K880480	Dunford Surgeon's Sterile Gloves	Phillippine Radiant C/O U.S. Polymer Industries	KGO	Class I	1988-06-17
K880185	Duet (Condoms)	American Laboratories, Inc.	HIS	Class II	1988-06-17
K875212	Pxs Model Pxs7-730Ea Dental X-Ray Source	Kevex Corp.	EHD	Class II	1988-06-17
K873606	Modified Cope Suture Anchor	Cook Inc.	FGE	Class II	1988-06-17
K882357	Microscope Slides Precoated W/histogrip & Poly-Ly	Stat Path	KEW	Class I	1988-06-16
K882335	Disposable Syringe	Baxter Healthcare Corporation	FMF	Class II	1988-06-16
K882320	Kodak Ektascan Laser Printer Adapter, Model M6/m8	Eastman Kodak Company	IXW	Class II	1988-06-16
K882278	Resuscitation Bag Controller (Rbc)	Physician Engineered Products, Inc.	BTM	Class II	1988-06-16
K882078	Spinal Surgery Frame	Karlin Technology, Inc.	FWZ	Class I	1988-06-16
K882075	Self-Retaining Soft Tissue Retractor	Karlin Technology, Inc.	GAD	Class I	1988-06-16
K882074	Suction Retractors	Karlin Technology, Inc.	GAD	Class I	1988-06-16
K881925	Vitek Yeast Biochemical Card	Vitek Systems, Inc.	JXB	Class I	1988-06-16
K881872	TENS Electrode Model 238P	Lectec Corp.	GXY	Class II	1988-06-16
K881871	Spare Ms 700 TENS Electrode	Lectec Corp.	GXY	Class II	1988-06-16