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 2445 of 3531

510(k) clearances, page 2445 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K910244	Global Care Micro II	Globalcare Intl., Inc.	GZJ	Class II	1991-07-09
K905698	Cordis Opta 5	Cordis US Corp.	LIT	Class II	1991-07-09
K904450	Bioceram Dental Implant, Series II	Kyocera America, Inc.	DZE	Class II	1991-07-09
K904398	Water Column Relief Valve	Icn Pharmaceuticals, Inc.	CAF	Class II	1991-07-09
K903488	Meridien Dental Systems	Anco Merchandise Co., Ltd.	JEQ	Class I	1991-07-09
K900385	Acta Metra/acta Gnosis Firmware Package	Parexel Intl. Corp.	DSI	Class II	1991-07-09
K912651	Airsafe Minivac Smoke Filtration System	Stackhouse Assoc.	FYD	Class II	1991-07-08
K912231	Proposed New Use of Instrument System and Test Kit	Intl. Immunoassay Laboratories, Inc.	JHW	Class II	1991-07-08
K911907	Fluidshield Cone Classic II Surg Mask W/splash Vis	Tecnol New Jersey Wound Care, Inc.	FXX	Class II	1991-07-08
K911554	Aim Tibial Nail	Ace Medical	HSB	Class II	1991-07-08
K912043	Accu-Vent(tm) with Needle-Pro(tm)	Concord/Portex	CBT	Class I	1991-07-05
K911688	Innofluor(tm) Valproic Acid Reagent Set	Intl. Bioclinical, Inc.	LEG	Class II	1991-07-05
K911589	Disposable Surgical Trocar with Seal	Applied Vascular Devices, Inc.	GCJ	Class II	1991-07-05
K911576	Chemotherapy Container	Bemis Mfg. Co.	KPE	Class II	1991-07-05
K911560	Zephyr Infusion Catheter	Target Therapeutics	DQO	Class II	1991-07-05
K911547	Magnum-Meier Recanalization Guidewire	Schneider Intl., Ltd.	DQX	Class II	1991-07-05
K911407	Harding Sternal Shield	Harding Medical Devices	EYF	Class I	1991-07-05
K911286	Pulpdent Orthodontic Bracket Adhesive	Pulpdent Corporation	DYH	Class II	1991-07-05
K911164	Reich Suction/irrigation Cannula	Marlo Surgical Technology	GCJ	Class II	1991-07-05
K911149	Pal (Probe for Aspiration and Lavage)	Marlo Surgical Technology	GCJ	Class II	1991-07-05
K911070	Picc-Fix	Sorex Medical	KMK	Class I	1991-07-05
K910985	Single-Use Laparoscopic Suction/irrigation Cannula	Precision Laser Products, Inc.	GCJ	Class II	1991-07-05
K904824	Easy Eyes Tm Contact Lens Cleaning Machine	Eaton Medical Corp.	LYL	Class II	1991-07-05
K903835	Acetate-Free Dialyslate Solution	Physio, Inc.	KPO	Class II	1991-07-05
K902331	Bud Dental Implant System	Bud Industries, Inc.	DZE	Class II	1991-07-05
K903515	Hh-1119 Healing Head	Minimatic Implant Technology	DZE	Class II	1991-07-04
K911805	Kin-Com Asymmetrical Back System	Chattanooga Group, Inc.	IKK	Class II	1991-07-03
K911800	Coil Field Extender	Resonex, Inc.	LNH	Class II	1991-07-03
K911666	Medx Machine	Medx Corp.	IKK	Class II	1991-07-03
K911594	Oralcam	Charmac Group, Inc.	EIA	Class I	1991-07-03
K911474	Laparoscopic Forceps	United States Endoscopy Group, Inc.	HCZ	Class II	1991-07-03
K911291	All-Pro 100	All-Pro Imaging Corp.	IXW	Class II	1991-07-03
K911098	Philips Uro Diagnost Mrf	Philips North America LLC	IXR	Class II	1991-07-03
K911075	Coloscreen	Helena Laboratories, Corp.	KHE	Class II	1991-07-03
K910967	Neurocam	GE Healthcare	IYX	Class I	1991-07-03
K905798	Colocare	Helena Laboratories, Corp.	KHE	Class II	1991-07-03
K912567	Conicast, Intracast, Omecast	Metalor Dental USA Corp.	EGG	Class I	1991-07-02
K912315	V-Delta S1	Metalor Dental USA Corp.	EJS	Class II	1991-07-02
K912314	800 Solder	Metalor Dental USA Corp.	EJS	Class II	1991-07-02
K912108	Blades, Whiskers, Trimmers, Cutters, and Burs	Microaire Advanced Surgical Products	HRX	Class II	1991-07-02
K912042	Bethel Plus Multiple Names	Bethel Latex Products, Inc.	LZB	Class I	1991-07-02
K911930	Sterile Packaged Power Instrument Accessories	United American Medical Co., Inc.	HWE	Class I	1991-07-02
K911929	Small Bone Fixation System	United American Medical Co., Inc.	HWE	Class I	1991-07-02
K911905	Deknatel(r) Microflex Ophthal Poly Suture,modified	Deknatel, Inc.	GAW	Class II	1991-07-02
K911586	General Hospital Tubing Clamp (Non-Electric)	Megadyne Medical Products, Inc	BYY	Class II	1991-07-02
K911545	V-Delta	Metalor Dental USA Corp.	EJS	Class II	1991-07-02
K911494	Needle Cannula	United States Endoscopy Group, Inc.	GCJ	Class II	1991-07-02
K911491	Laparoscopic Electrode	United States Endoscopy Group, Inc.	GEI	Class II	1991-07-02
K911490	Laparoscope Support Arm	United States Endoscopy Group, Inc.	GCJ	Class II	1991-07-02
K911489	Palpatation and Measuring Stick	United States Endoscopy Group, Inc.	GCJ	Class II	1991-07-02