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 2049 of 3531

510(k) clearances, page 2049 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K953924	Xls-300 Xenon Light Source	Specialties of Surgery	GCT	Class II	1995-09-21
K953836	Abutment	Steri-Oss, Inc.	DZE	Class II	1995-09-21
K953775	Brandemark Accessories to Ceramic Abutyment (Ceramicore)	Nobelpharma USA, Inc.	DZE	Class II	1995-09-21
K953126	Oxilink (Small, Medium, Large)	Bci Intl., Inc.	DQA	Class II	1995-09-21
K953023	Preceder Guidewire	Boston Scientific Corporation	DQX	Class II	1995-09-21
K952592	Opti-Max Internal-Hex Angled Implant Crown Post, 10 Degree & 20 Degree Inclinations	Opti-Max	DZE	Class II	1995-09-21
K952427	Cx Alanine, Cx Aspartate Aminotransferase-Pyridoxal-5-Phosphate, Cx Creatine Phosphokinase-N-Acetyl-L-Cysteine	Beckman Instruments, Inc.	CKA	Class I	1995-09-21
K952338	Sta-Coag Control [P] Plus Kit	American Bioproducts Co.	GGC	Class II	1995-09-21
K952218	Jt-3 Electrognathograph	Bio-Research Associates, Inc.	NFS	Class I	1995-09-21
K952160	Intravascular (I-V) Admininistration Set (Dvgenpers Fpa)	Medex, Inc.	FPA	Class II	1995-09-21
K952058	Sterile V.a.d. (Vascular Access Devices) Access Kit, Disposable	Trinity Laboratories, Inc.	FOZ	Class II	1995-09-21
K950803	Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 Sample	Isolab, Inc.	JJT	Class I	1995-09-21
K950331	Pressure Support Ventilatory Assist System (Psvas)	Healthdyne, Inc.	BZD	Class II	1995-09-21
K945500	Wells Johnson Fixation System	Wells Johnson Co.	JEY	Class II	1995-09-21
K943180	Integral IV Biointegrated Dental Implant System	Calcitek, Inc.	DZE	Class II	1995-09-21
K926370	Straight 3.25 Mm Dental Implant Attachments	International Implant Seminars	DZE	Class II	1995-09-21
K926367	Phoenix 3.25 Mm Ha Coated Dental Implant	International Implant Seminars	DZE	Class II	1995-09-21
K926366	Phoenix 3.25 Mm C.p. Coated Dental Implant	International Implant Seminars	DZE	Class II	1995-09-21
K926311	Phoenix 4.0 Mm Angled Dental Attachments	Vancouver Implant Center	DZE	Class II	1995-09-21
K926309	Phoenix 4.0 Mm Dental Implant	Vancouver Implant Center	DZE	Class II	1995-09-21
K953845	Abuscreen Online Drug Free Urine	Roche Diagnostic Systems, Inc.	DIF	Class I	1995-09-20
K953739	Abuscreen Online Controls	Roche Diagnostic Systems, Inc.	DIF	Class I	1995-09-20
K953463	Vacutainer Plus Tubes	Becton Dickinson Vacutainer Systems	JKA	Class II	1995-09-20
K952862	Fuji Computed Radiography System Fcr9501es.fcr	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	1995-09-20
K952720	Aalto Scientific Ltd. Glycated Hemoglobin Control Levels I & II	Aalto Scientific Ltd.	JPK	Class II	1995-09-20
K951213	Relaxplus	Ultramind International, Ltd.	HCC	Class II	1995-09-20
K942706	Roche Calibrator Serum	Roche Diagnostic Systems, Inc.	JIX	Class II	1995-09-20
K941252	Respiratory and Cardiac Spectral Frequency Signal Processor	Ansar	DRT	Class II	1995-09-20
K935712	Iron/tibc Reagent	Horizon Diagnostics, Inc.	JIY	Class I	1995-09-20
K953951	Wilson-Cook Triple Lumen Balloon Stone Extractor	Wilson-Cook Medical Inc.	GCA	Class II	1995-09-19
K953824	Lifemask Face Shield	Carefree Trading, Inc.	BTM	Class II	1995-09-19
K953788	Unicor, Inc. Gas Sampling Lines & Connectors	Unicor, Inc.	CAI	Class I	1995-09-19
K953787	Unicor, Inc. Adult Anesthesia Breathing Circuit	Unicor, Inc.	CAI	Class I	1995-09-19
K953786	Unicor, Inc. Connectors & Airway Extensions	Unicor, Inc.	BZA	Class I	1995-09-19
K953784	Unicor, Inc. Corrugated Tubing	Unicor, Inc.	BZO	Class I	1995-09-19
K953548	Laparoscopic Surgical Instrument	Gabris Surgical Corp.	HET	Class II	1995-09-19
K953515	Scimed Triguide Guide Catheters	Scimed Life Systems, Inc.	DQY	Class II	1995-09-19
K953073	Low Profile Titanium Model Catalog #1003	Arrow Intl., Inc.	LJT	Class II	1995-09-19
K952838	Medical Mixture-Lung Diffusion Gas Mixtures	Standard Welders Supply Co.	BXK	Class I	1995-09-19
K952686	Buchalter Fauser Femoral Components	Zimmer GmbH	LZO	Class II	1995-09-19
K952651	Life Sound Sensor	Flowscan, Inc.	DQC	Class I	1995-09-19
K952080	Clarity System II	Sonamed Corp.	GWJ	Class II	1995-09-19
K952068	Ethylene Oxide Sterilization of Polyethylene Orthopedic Devices	Zimmer GmbH	HSX	Class II	1995-09-19
K951666	Stryker Interpulse Handpiece Set, Irrigation Tips, Splash Shields, Canal Vision Tip, Irrigation & Suction Tips	Stryker Corp.	FQH	Class II	1995-09-19
K951074	Stomavision (Stv)	Trophy Radiologie	EIA	Class I	1995-09-19
K950273	Sleep Test(tm)	Cns, Inc.	MNR	Class II	1995-09-19
K945791	Gyres 2T Prestige	Elscint, Inc.	LNH	Class II	1995-09-19
K945633	Neuro Channel Endoscope Model 2232	Clarus Medical Systems, Inc.	GWG	Class II	1995-09-19
K945482	Disposable, CPAP Oxygen Mask	Fvtnks	BYG	Class I	1995-09-19
K944547	Dantec Keypoint	Mckenna & Cuneo	GWF	Class II	1995-09-19