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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2503 of 3531

510(k) clearances, page 2503 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903908	Repak Surgical Packs	Repack Surgical Enterprises, Inc.	KKX	Class II	1990-10-26
K903902	Sunglasses	K & P Trading Co., Inc.	HQY	Class I	1990-10-26
K903759	Irriclear Ear Irrigation Syringe	Nortech Laboratories, Inc.	KYZ	Class I	1990-10-26
K903755	Cat/ #4100-21 Shoulder Coil Package, Modified	Medical Advances, Inc.	LNH	Class II	1990-10-26
K903754	Cat. #4050-64 & 4065-64 Shoulder Coils, Modified	Medical Advances, Inc.	LNH	Class II	1990-10-26
K903753	Cat. #6000-21 Volume Neck Coil, Modified	Medical Advances, Inc.	LNH	Class II	1990-10-26
K903725	Ez-Bead Tsh Enzyme Immunoassay Kit	IMMUNOTECH s.r.o.	JLW	Class II	1990-10-26
K903709	Surgimedics, Slp Laparoscopic Cholangiogram Cath	Lifestream Int'L, Inc.	GBZ	Class I	1990-10-26
K903611	Ilc Leg Bag Holder	Inman Liebelt Corp.	FAQ	Class I	1990-10-26
K903492	Dsl Erythropoietin (Dsl # 1100)	Diagnostic Systems Laboratories, Inc.	GGT	Class II	1990-10-26
K903459	Precision Optics Endoscope Adapter	Precise Optics	FET	Class II	1990-10-26
K903142	Aukuflex(tm) Radiation Resistant Gloves	Aukland Mfg., Inc.	LZC	Class I	1990-10-26
K903111	Latex Examination Gloves	Kaen Yang Industry Co., Ltd.	LYY	Class I	1990-10-26
K903017	Mega-TENS Dual Channel t.e.n.s.	Futuremed Div. of Future Impex Corp.	GZJ	Class II	1990-10-26
K902984	G.e. Amx 110, Amx II and Amx 3 X-Ray Units	Electromek Diagnostic Systems, Inc.	IZL	Class II	1990-10-26
K902625	Clinical Thermometer; Rectal/oral, Inner Armpit	Liaoning-Usa Corp.	FLK	Class II	1990-10-26
K902299	CPR Valve (Non-Rebreathing) Model #9030	Rondex Products, Inc.	CBP	Class II	1990-10-26
K902113	Vitalograph - Breathco Monitor	Mcneill Intl., Inc.	CCJ	Class II	1990-10-26
K901922	Safte Orione Hernia Belt Items No. 316, 515, 536	Safte S.p.A.	EXN	Class I	1990-10-26
K901494	Etude, Urodynamic Investigation System	Dantec Medical, Inc.	FAP	Class II	1990-10-26
K900923	Zimmon Endoscopic Pancreatic Stent	Wilson-Cook Medical Inc.	FGE	Class II	1990-10-26
K900315	Percussionaire Txp Transporter/respirators 750 Min	Percussionaire Corp.	CBK	Class II	1990-10-26
K900314	Percussionaire(r) Oscillatron-1 Percuss 1300 Min	Percussionaire Corp.	CBK	Class II	1990-10-26
K900313	Percussionaire(r) Vdr-3 Imv Percus/respir 1250 Min	Percussionaire Corp.	CBK	Class II	1990-10-26
K895677	The Murray Mobilift(tm)	Medical/Surgical Specialties, Ltd.	FNG	Class II	1990-10-26
K904052	Supramid Extra Sutures	S. Jackson, Inc.	GAR	Class II	1990-10-25
K903029	Sterile Black Monofilament Nylon Non-Absor. Suture	Look, Inc.	GAR	Class II	1990-10-25
K902104	Orion Watchguard	Orion Industries	HFM	Class II	1990-10-25
K903568	Super Strength Denture Adhesive Cream	Teledyne Getz	KOT	Class I	1990-10-24
K903537	250 Sl Dental Casting Alloy	Leach and Dillon Co., Inc.	EJT	Class II	1990-10-24
K903455	A-Dec Decade Cuspidor	A-dec, Inc.	EIA	Class I	1990-10-24
K903454	A-Dec Decade 1010 Chair	A-dec, Inc.	KLC	Class I	1990-10-24
K903453	A-Dec Ic Micro-Cart	A-dec, Inc.	EIA	Class I	1990-10-24
K903452	A-Dec Ic Control Head	A-dec, Inc.	EIA	Class I	1990-10-24
K903451	A-Dec Pac I Portable Unit	A-dec, Inc.	EIA	Class I	1990-10-24
K903450	A-Dec Decade 1015 Chair	A-dec, Inc.	KLC	Class I	1990-10-24
K903066	Amplaid 770 Admittance Meter	Amplus Corp.	ETY	Class II	1990-10-24
K902863	Palladius-V and Palladius-Ag Semi-Precious Alloy	Vident	EJT	Class II	1990-10-24
K901549	Cns Satellite 100, 200, 1000, 2000 Electroence.	Cns, Inc.	GWQ	Class II	1990-10-24
K904464	Cbc-Laser(r) Hematology Control/multiple-Modified	R & D Systems, Inc.	JPK	Class II	1990-10-23
K904412	Allevyn Dressing Claims Change	Smith & Nephew United, Inc.	KOZ	Class I	1990-10-23
K903988	Panoramic Omega Imaging Table	Med-Tron Products, Inc.	IYX	Class I	1990-10-23
K903919	Implantable Pulse Devices	Medtronic, Inc.	DXY	Class III	1990-10-23
K903780	Auto Suture Laparoscopy Accessory Kit	United States Surgical, A Division of Tyco Healthc	HET	Class II	1990-10-23
K903523	Hp Model M1020a, Arterial Oxygen Sat/pleth Module	Hewlett-Packard Co.	DQA	Class II	1990-10-23
K903486	Mask, Surgical-Disposable Nsn 6510-00-982-7493	Pennsylvania Association for the Blind	FXX	Class II	1990-10-23
K903342	Deodorizing and Sound Muffling Anal Pad	Biological Resistance, Inc.	EYQ	Class I	1990-10-23
K903330	Mallinckrodt Medical, Inc., Infussion Catherter	Mallinckrodt Medical	DQY	Class II	1990-10-23
K903116	Rm Isoelastic Bevelled Acetabular Cup	Robert Mathys Co.	JDI	Class II	1990-10-23
K902980	G.e. Xt Ceiling Tube Suspension	Electromek Diagnostic Systems, Inc.	JAA	Class II	1990-10-23