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 2507 of 3531

510(k) clearances, page 2507 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903124	Laparoscopic Access Sheath Set	Cook Inc.	HET	Class II	1990-10-12
K902786	Milenia (Tm) Lh	Siemens Healthcare Diagnostics Inc.	CEP	Class I	1990-10-12
K902533	Pulsed Selectron	Nucletron-Oldelft Corp.	JAQ	Class II	1990-10-12
K902240	Vet (Vacuum Erection Technology)	Vetco, Inc.	LKY	Class II	1990-10-12
K902164	Syb, or Save Your Breath Tongue Cleaner	P.J., Inc.	LCN	Class I	1990-10-12
K904345	Fashion Frames	Sunland Optical Co.	HQZ	Class I	1990-10-11
K904316	Nouvelle (Tm) Model #901, Sizes 0-12, Left & Right	MEDLINE INDUSTRIES, LP - Northfield	KCZ	Class I	1990-10-11
K904242	Qi-Gong Machine Therapeutic Massager	China Healthways Institute	ISA	Class I	1990-10-11
K904133	Disposable Fluid Collection Bag	Axiom Medical, Inc.	GBX	Class I	1990-10-11
K904119	Profile Collared Hip Prosthesis	Depuy, Inc.	KWL	Class II	1990-10-11
K903987	Triflex(r) Orth Sterile Surgeon's Gloves, Modified	Baxter Healthcare Corporation	KGO	Class I	1990-10-11
K903721	Wrap-Around Instant Sunglasses	Yorktowne Optical Co., Inc.	HQY	Class I	1990-10-11
K903720	Flat Fit-in Sunglasses	Yorktowne Optical Co., Inc.	HQY	Class I	1990-10-11
K903719	Flat Slip-in Sunglasses	Yorktowne Optical Co., Inc.	HQY	Class I	1990-10-11
K903584	Polypropylene Nonabsorbable Surgical Sutures	Look, Inc.	GAW	Class II	1990-10-11
K903444	Mdls 4000/4900/6000/8000/8900/Luxus 60/100 Nd:yag	Heraeus Lasersonics, Inc.	GEX	Class II	1990-10-11
K903303	Spembly Medical 242 Cryounit/series 242 Cryoprobes	Spembly Medical, Ltd.	HPS	Class II	1990-10-11
K903230	Sharplan CO2 Lasers, Model Numbers 1050 and 1075	Sharplan Lasers, Inc.	GEX	Class II	1990-10-11
K903205	Auto Suture(r) Endoscopic Clamp	United States Surgical, A Division of Tyco Healthc	HDA	Class II	1990-10-11
K903138	Marquest Sct 3000, Heated Humidification System	Marquest Medical Products, Inc.	BTT	Class II	1990-10-11
K903093	Iontophoresis Device	Empi	EGJ	Class II	1990-10-11
K902224	Sunglasses	Jasco Products Co., Inc.	HQY	Class I	1990-10-11
K904130	Chemo Gloves Powder Free (Mfg: Union Industrial)	Biosafety Systems, Inc.	LYY	Class I	1990-10-10
K904026	Inflat-O-Ball	Milex Products, Inc.	HHW	Class II	1990-10-10
K904008	Stage IV, Air-Fluidize Bed	Unique Flotation Systems, Inc.	INX	Class II	1990-10-10
K903858	Cook-Gianturco Rosch Biliary Z-Stent, Modification	Cook Inc.	FGE	Class II	1990-10-10
K903234	F-19 Total Hip Prosthesis	Med-Tek Corp.	JDI	Class II	1990-10-10
K903220	Port-a-Cath Implantable Drug Delivery System	Pharmacia Deltec, Inc.	LJT	Class II	1990-10-10
K903163	Periodontal Debriding Solution E	Dentsply Intl.	ELC	Class II	1990-10-10
K901862	Vmk 68 and Vmk 68N Dental Porcelain Kit	Vident	EIH	Class II	1990-10-10
K901288	Davol Scope Irrigation System	C.R. Bard Inc	HIG	Class II	1990-10-10
K901144	Levtech Bone Screw	Levtech, Inc.	HWC	Class II	1990-10-10
K904270	Biolink Audiometer Software Accessory	Micro Audiometrics Corporation	EWO	Class II	1990-10-09
K904120	Accu-Flo* Unitized Shunt	Cerenovus, Inc.	JXG	Class II	1990-10-09
K904021	Pneumothorax Kit, Modification	Arrow Intl., Inc.	JDC	Class II	1990-10-09
K903960	Model 9444 Teletrace II ECG Monitoring System	Medtronic, Inc.	DXH	Class II	1990-10-09
K903865	Ite Hearing Aid, Sound Med Amethyst Model	Improved Hearing Service, Inc.	ESD	Class I	1990-10-09
K903864	Ite Hearing Aid, Pearl Model	Improved Hearing Service, Inc.	ESD	Class I	1990-10-09
K903863	Ite Hearing Aid, Sound Med Opal Model	Improved Hearing Service, Inc.	ESD	Class I	1990-10-09
K903862	Ite Hearing Aid, Sound Med Ruby Model	Improved Hearing Service, Inc.	ESD	Class I	1990-10-09
K903861	Ite Hearing Aid, Sound Med Golden Nugget Model	Improved Hearing Service, Inc.	ESD	Class I	1990-10-09
K903860	Ite Hearing Aid, Saaphire Model	Improved Hearing Service, Inc.	ESD	Class I	1990-10-09
K903859	Ite Hearing Aid, Diamond Model	Improved Hearing Service, Inc.	ESD	Class I	1990-10-09
K903736	Datascope Percor Stat Dl10.5 Fr40cc in Aortic Bal	Datascope Corp.	DSP	Class II	1990-10-09
K903633	Advance Laser Flowmeter, Alf 21	Transonic Systems Inc	DPW	Class II	1990-10-09
K903587	Heliolink Try-in Pastes	Ivoclar North America, Inc.	EBF	Class II	1990-10-09
K903583	Series Mcaxx (Model 851) Ite Hearing Aid	Maico Hearing Instruments, Inc.	ESD	Class I	1990-10-09
K903503	Scimed Encore Inflation Device, Model Sm2500	Scimed	MAV	Class II	1990-10-09
K903500	Mascot Thermoter	Mascot, Inc.	FLK	Class II	1990-10-09
K903479	Audiotech Model Db	Muskogee Regional Hearing Aid Lab	ESD	Class I	1990-10-09