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 2477 of 3531

510(k) clearances, page 2477 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K905139	Cathlab Silicone Arterial Embolectomy Catheter	Cathlab Corp.	DXE	Class II	1991-02-25
K904978	Software Program Used W/prism Products	Prism Imaging, Inc.	DXK	Class II	1991-02-25
K904977	Cine/view Plus - Cardiology Workstation	Prism Imaging, Inc.	DXK	Class II	1991-02-25
K904976	Cine'view - Stress Echo & Image Review	Prism Imaging, Inc.	DXK	Class II	1991-02-25
K904975	Vista Viewing Station	Prism Imaging, Inc.	DXK	Class II	1991-02-25
K904582	Quickwire - Hydrophilic Coated Guidewire	Meadox Surgimed, Inc.	DQX	Class II	1991-02-25
K904406	Eer Erection Enhanced Responder	Eer, Inc.	LKY	Class II	1991-02-25
K904250	Model 4222 Ambulatory ECG Monitor	Byrncrest Global, Inc.	DXH	Class II	1991-02-25
K904118	Somniprobe II Nasal and Buccal Airflow Mon. Syst.	Dawn Medical	BZG	Class II	1991-02-25
K904117	Somnigauge Thoracic/abdominal Expansion Mon. Syst.	Dawn Medical	BZG	Class II	1991-02-25
K903991	Pcm Anesthesia	Siemens Life Support Systems	BSZ	Class II	1991-02-25
K902628	Interflo Medical Model Interflo/1 Cardiac Output	Biometric Research Institute, Inc.	DXG	Class II	1991-02-25
K902627	Interflo Medical Model Oxi/co Fila. Thermo. Cath.	Biometric Research Institute, Inc.	KRB	Class II	1991-02-25
K902327	Embolectomy Catheter	Clincal Instruments Corp.	DXE	Class II	1991-02-25
K902288	Modified Lifepak 9 Monitor/defibrillator	Physio Control, Inc.	LDD	Class II	1991-02-25
K910376	Emit II Benzodiazepine Assay	Syva Co.	JXM	Class II	1991-02-22
K910302	Eclipse Ica Analyzer	Biotope, Inc.	JJQ	Class I	1991-02-22
K910256	Eclipse Ica Tsh	Biotope, Inc.	JLW	Class II	1991-02-22
K905623	Ck-Mb Immunoassay Control	Seradyn, Inc.	JJT	Class I	1991-02-22
K900677	Accent Dg(tm) Balloon Angioplasty Catheter	Cook Inc.	LIT	Class II	1991-02-22
K910607	Pacific Marquis Spa	Marquis International, Ltd.	ILJ	Class II	1991-02-21
K910334	Electrocautery Probe	Wiltek Medical, Inc.	GEI	Class II	1991-02-21
K910184	Plp Laparoscopic Cholecystectomy Dis. Elec. Probes	Precision Laser Products, Inc.	GEI	Class II	1991-02-21
K910132	Stryker Laparoscope	Stryker Corp.	GCJ	Class II	1991-02-21
K910042	Ebv Igm Elisa Test	Gull Laboratories, Inc.	LJN	Class I	1991-02-21
K905790	Total Protein Reagent Set	Biochemical Trade, Inc.	CEK	Class II	1991-02-21
K905721	Opus Gentamicin	Pb Diagnostic Systems, Inc.	LCQ	Class II	1991-02-21
K905710	Pharmacia Delfia Neonatal Htsh Kit	Pharmacia, Inc.	JLW	Class II	1991-02-21
K905625	Cvis Insight Imaging Catheter	Cardiovascular Imaging Systems, Inc.	DQO	Class II	1991-02-21
K905612	Ventrex Coated Tube Ige Radioimmunoassay	Ventrex Laboratories, Inc.	DGC	Class II	1991-02-21
K905565	Lateral Buttress Support	Mcconnell Orthopedic	FWZ	Class I	1991-02-21
K905564	Prep and Operating Stand	Mcconnell Orthopedic	FWZ	Class I	1991-02-21
K905529	Valleylab E1554 Reduced Eschar Electrode	Medtronic, Inc.	GEI	Class II	1991-02-21
K905433	Codman Disposable Scalp Clip Applier	Cerenovus, Inc.	HBO	Class II	1991-02-21
K905209	Surgical Mask	Lancaster County Blind Assoc.	FXX	Class II	1991-02-21
K905006	Surgilase Sl 150 Surgical Laser System	Surgilase, Inc.	GEX	Class II	1991-02-21
K905004	Bio-Guard o.r. Scrub Prep Tray	Network Medical Systems, Inc.	LRO	Class II	1991-02-21
K904973	External Fixation	Dynasplint Systems, Inc.	KTT	Class II	1991-02-21
K904957	Sterile and Non-Sterile Textile Packs	Surgical Pack Services, Inc.	KKX	Class II	1991-02-21
K904638	Trocar Disposable	L.A.S.E.R., Inc.	FBQ	Class II	1991-02-21
K903485	Titanium Mesh	Ruggles Corp.	GWO	Class II	1991-02-21
K910115	Philips Bv-29 Imaging System	Philips North America LLC	OXO	Class II	1991-02-20
K910038	Lorenz Ultra-Micro Titanium Osteosynthesis System	Biomet Microfixation	JEY	Class II	1991-02-20
K905639	Torque Handle Device for Guidewire	Lake Region Mfg., Inc.	DQX	Class II	1991-02-20
K905524	Retic-Chex	Streck Laboratories, Inc.	JPK	Class II	1991-02-20
K905476	Stomadent Tm	Dentsply Intl.	EBF	Class II	1991-02-20
K905401	Aseptimini Unit, Adu-10	Aseptico, Inc.	EIA	Class I	1991-02-20
K905213	Middle Ear Analyzer, Model Ae-803	American Electromedics Corp.	ETY	Class II	1991-02-20
K905163	Nitrate Disk	Remel Inc	JTO	Class I	1991-02-20
K902435	Dia Impression Coping	Dental Imaging Assoc., Inc.	DZE	Class II	1991-02-20