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 2026-10-21, 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 2990 of 3529

510(k) clearances, page 2990 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850750	Disposable Urostomy Pouch	Biolog, Inc.	EXB	Class I	1985-05-23
K850496	Transport Incubator 185	Airborne Life Support Systems, Inc.	FPL	Class II	1985-05-23
K844790	Renaflo Hemoconcentrator	Renal Systems, Inc.	KDI	Class II	1985-05-23
K843539	Teledyne Densco Dry Tips Saliva Absorb-	Molnlycke A/S Hospital Products	EFN	Class I	1985-05-23
K852063	Playtex Slender Reg. Tampons & Deodorant Tampons	Intl. Playtex, Inc.	HEB	Class II	1985-05-22
K852026	Femoral Proximal Diagnosal Screw, Femoral Transver	Warsaw Orthopedic, Inc.	HWC	Class II	1985-05-22
K852020	Interlocking Femoral Nail(left & Right) Tibial Nai	Warsaw Orthopedic, Inc.	HSB	Class II	1985-05-22
K851949	Staphaurex Zl30	Wellcome Diagnostics	GTN	Class I	1985-05-22
K851799	61-100 to 61-124 Various Vaginal Specvia(cusco,gra	Artiberia	HDF	Class I	1985-05-22
K851696	Ausonics 150	Ausonics Pty, Ltd.	IYO	Class II	1985-05-22
K851291	Lovesafe Plain Condom 1/4 Dz. Condoms/box Pc-30	Manexim Multicorp, Ltd.	HIS	Class II	1985-05-22
K851290	Lobesafe Plain Condom Dozen Condoms/box,pc-10	Manexim Multicorp, Ltd.	HIS	Class II	1985-05-22
K851252	Corometrics 115 Fetal Monitor W/dual Cardiotachome	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1985-05-22
K851231	Rmc Posterior Stabilized Knee System	Richards Medical Co., Inc.	JWH	Class II	1985-05-22
K851229	Codman Arthroscope	Cerenovus, Inc.	HRX	Class II	1985-05-22
K851096	Hpu Heat Probe Automated Electrocautery System	Olympus Corp.	KNS	Class II	1985-05-22
K850650	Dental Acrylic Polymers	Cole Polymers, Ltd.	EBI	Class II	1985-05-22
K850632	Pms Amniocentesis Tray/kit	Professional Medical Services	HIO	Class I	1985-05-22
K850340	Eye Procedure Pack	Marwood Medical, Inc.	HOZ	Class II	1985-05-22
K844592	Mta 86	Madsen Electronics (Canada), Ltd.			1985-05-22
K844031	Sonomed Tech Ophthalmic B-Scan B-3000	Sonomed Technology, Inc.	ITX	Class II	1985-05-22
K842983	Ampco Opthalmic Tray	Associated Medical Products Co.	HOZ	Class II	1985-05-22
K851906	Surgical Eye Pack	Xanmed Corp.	HMP	Class I	1985-05-21
K851896	Double Action Pin Cutter	Med-Tool, Inc.			1985-05-21
K851880	Brimfield Scien. Instru. Dispos. Sterile Surg. Bla	J-Pac, LLC	GFA	Class I	1985-05-21
K851852	General Hospital Instruments	Biological & Environmental Control Laboratories			1985-05-21
K851705	Laryngoscope	Armstrong Ind., Inc.	CCW	Class I	1985-05-21
K851665	Pacesetter Systems, Model 458 Adapter Sleeve	Pacesetter Systems	DTD	Class II	1985-05-21
K851644	Spectrum 150 Dt	Raytheon Medical Systems	IYX	Class I	1985-05-21
K851459	Visilux 2 Visible Light Curing Unit	3M Company	EBF	Class II	1985-05-21
K851428	Tranducer Protector	Galvin Industries, Inc.	FIB	Class II	1985-05-21
K851367	Ha-1000 & Ha-500 Hydroxylapatite-Modification	Orthomatrix, Inc.	DZE	Class II	1985-05-21
K851325	Microcor ECG Monitor	Microcor, Inc.	DRT	Class II	1985-05-21
K851273	Phadebas Rast Phadezym Rast Allertubes	Pharmacia, Inc.	DHB	Class II	1985-05-21
K851086	Vicryl (Polyglactin 910/Mersilene Compoisite Mesh	Ethicon, Inc	FTM	Class II	1985-05-21
K851067	Canon X-Ray Film Changer Cfc-U1	Canon Medical Components U.S.A., Inc.	KPX	Class II	1985-05-21
K851026	Moi-Stir Oral Swabstick(s)	Kingswood Laboratories, Inc.	LFD	Unclassified	1985-05-21
K851021	Mayfield Table-Electric	Ohio Medical Instrument Co., Inc.	GDC	Class I	1985-05-21
K851006	T-Swipe -Tongue Cleaner	Kumar Ent.	LCN	Class I	1985-05-21
K851005	Xro Umbilical Catheter-Code 270	Vygon Corp.	FOS	Class II	1985-05-21
K850925	Blood Tubing(pvc) 201458 W/(totm) Plasticizer	American Bentley	DWF	Class II	1985-05-21
K850917	Argyle Griffith Tdmac Heparinized Veno-Venous Shun	Sherwood Medical Co.	DWF	Class II	1985-05-21
K850649	Absorbable Intracanalicular Collagen Implant	Lacrimedics, Inc.			1985-05-21
K850419	Auto Turner	George J. Kamilar	FNM	Class II	1985-05-21
K850011	Provac Wound Healing/suction Set	Medical Matrix, Inc.	GCY	Class I	1985-05-21
K845049	Z0174, Impedance Audiometer	Madsen Electronics (Canada), Ltd.	ETY	Class II	1985-05-21
K844854	Opti-Flow Digital Subtraction Angiography Cat-Kit	Vas-Cath of Canada, Ltd.	DQO	Class II	1985-05-21
K844780	Europlate-Conductive Adhesive Electrosurgical Retu	Poly-Med, Inc.	GEI	Class II	1985-05-21
K844707	Quantum 84	Cadwell Laboratories, Inc.	GWF	Class II	1985-05-21
K844436	Virogen Rubella Microtiter Test	Armkel, LLC	LQN	Class II	1985-05-21