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 2026-11-05, 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 2071 of 3531

510(k) clearances, page 2071 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951844	Biomechanic Low-Profile Cable System	Biomechanic, Inc.	JDQ	Class II	1995-07-13
K951809	Gliding Nail	Encore Orthopedics, Inc.	KTT	Class II	1995-07-13
K950085	Multicure(r) S Gel Pad	Multigestion (Deutschland) GmbH	KIC	Class I	1995-07-13
K950075	Med-Tec Tray Adapter	Medtec LLC	IYE	Class II	1995-07-13
K946362	Silon Silicone Foam Sheeting	Bio Med Sciences, Inc.	MDA	Class I	1995-07-13
K945099	Parameters Monitores	Ivy Biomedical Systems, Inc.	MHX	Class II	1995-07-13
K944507	Metallic Radial Head Implants	Wrightmedicaltechnologyinc	KWI	Class II	1995-07-13
K942087	Biopool Vwf Eld Kit and Vwf Eld Bulk Plates	Biopool AB	GGP	Class II	1995-07-13
K940631	Cross Medical - Synergy(tm) Spine System	Cross Medical Products, Inc.	MNH	Class II	1995-07-13
K936305	Sensititre/pip/ta2 Susceptibility Plates	Radiometer America, Inc	JWY	Class II	1995-07-13
K953030	Slit Lamp Aia 11	Naveen Intl., Inc.	HJO	Class II	1995-07-12
K953012	Disposable & Reusable Surgical Cutting Tools	Boston Surgical Products, Inc.	GFA	Class I	1995-07-12
K953002	Metal Fram with Polycarbonate Lens	Nakanishi Optical Products Corp.	HQY	Class I	1995-07-12
K952925	Ready Nurse System (Rns) Trach Care Kit	Contour Fabricators of Florida, Inc.	LRQ	Class I	1995-07-12
K952890	Sunglasses	Isohyper	HQY	Class I	1995-07-12
K952822	Shimadzu X-Ray High Viltage Generator Ahd150g	Shimadzu Corp.	IZO	Class I	1995-07-12
K952420	Sterigauze Wet Dressing	Acacia Laboratories, Inc.	KMF	Class I	1995-07-12
K951947	Med-Tec Radio Therapy Treatment Chair	Medtec LLC	IYE	Class II	1995-07-12
K951925	Dicomit	Dicomit Imaging Systems Corp.	IYO	Class II	1995-07-12
K951862	A Gel Wound Dressing	Polymedica Industries, Inc.	MGQ	Unclassified	1995-07-12
K951679	Med-Tec Testicular Separator	Medtec LLC	IYE	Class II	1995-07-12
K950962	Karl Storz Hok Needle Holders, Forceps for Suturing, Suture Scissors, Tissue Probes, Injection Needle, Irrigation Instrt	Karl Storz Endoscopy-America, Inc.	HET	Class II	1995-07-12
K950595	Luhr Mandibular/small Fixation Implants	Howmedica Corp.	JEY	Class II	1995-07-12
K945321	Wellhofer Wp700 V. 3.2	Medical Physics Instrumentation, Inc.	IYE	Class II	1995-07-12
K943855	Bone Fixation Nail	Acu Med, Inc.	JDS	Class II	1995-07-12
K943616	Beltone Personal Hearing Screener	Beltone Electronics Corp.	EWO	Class II	1995-07-12
K943057	Cap Safe System	Medical Safety Solutions	FMI	Class II	1995-07-12
K942647	College of Amer Path (Cap) Surv Valid Prost Spec Anti	Scantibodies Laboratory Inc.	JJY	Class I	1995-07-12
K942271	Level 1* Inject Needle-Free Injection Site	Level 1 Technologies, Inc.	FPA	Class II	1995-07-12
K940039	Pellethane 75D	Medtronic, Inc.	DXY	Class III	1995-07-12
K915767	Model 143 Series Blood Product Irradiators	J. L. Shepherd and Assoc.	MOT	Unclassified	1995-07-12
K915766	Model 109 Series Blood Products Irradiators	J. L. Shepherd and Assoc.	MOT	Unclassified	1995-07-12
K952814	Ethicon Arthroscopic Knot Pusher	Ethicon, Inc	GCJ	Class II	1995-07-11
K952723	Devmed Reuseable Trocar System	Devmed Group, Inc.	GCJ	Class II	1995-07-11
K952689	Brigam Medical Disposable Anesthesia/respiratory Face Mask	Owens-Brigam Medical Co.	BSJ	Class I	1995-07-11
K952643	Right-on Adhesive Bouding System	TP Orthodontics, Inc.	DYH	Class II	1995-07-11
K952401	Abelson Cricothyrotomy Cannula	Gilbert Surgical Instruments, Inc.	BWC	Class II	1995-07-11
K952038	Clean-Cuff	Instrumed, Inc.	KCY	Class I	1995-07-11
K951930	Cementralizer Distal Stem Centralizer	Depuy, Inc.	LZN	Class II	1995-07-11
K951905	Scissors, Universal, Laparoscopic W/monopolar Cautery Reusable	H.S. Intl. Co., Inc.	GEI	Class II	1995-07-11
K951861	Stericare Wound Care Gel	Acacia Laboratories, Inc.	MGQ	Unclassified	1995-07-11
K951813	Caries Detector	Kuraray Co.	LFC	Class II	1995-07-11
K951721	Applied Medical 1.5Mm Reusable Angioscope	Applied Medical Resources Corp	LYK	Class II	1995-07-11
K951714	Cabot Medical-Surgitek Ultragold Plus Side-Firing Urologic Laser Fiber	Cabot Medical Corp.	GEX	Class II	1995-07-11
K951655	Duracon Recessed Patella	Howmedica Corp.	JWH	Class II	1995-07-11
K951642	Gold Cd Ultra Mini Canal - Module	Electone, Inc.	ESD	Class I	1995-07-11
K951538	Besure One-=Step Home Ovulation Predictor Kit	Syntron Bioresearch, Inc.	CEP	Class I	1995-07-11
K951162	Pheno-Cen Germicidal Detergent	Central Solutions, Inc.	LRJ	Class I	1995-07-11
K951134	Cedia Vitamin B12 (No Boil) Assay	Microgenics Corporation	CDD	Class II	1995-07-11
K951090	Introducer	Ranfac Corp.	GCJ	Class II	1995-07-11