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 2067 of 3531

510(k) clearances, page 2067 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951308	5.8Mm Diameter Anchor Screw	Advanced Spine Fixation Systems, Inc.	MNH	Class II	1995-07-26
K951007	More Chain Powder Free Vinyl Examination Gloves	Allerderm Laboratories, Inc.	LYZ	Class I	1995-07-26
K950966	Model 410Si-64 Shoulder Loop Pair, Small & Largem Nidek 410Si-42A Shoulder Loop Pair, Small & Large	Medical Advances, Inc.	MOS	Class II	1995-07-26
K950597	Core-Resistant Huber Infusion Set with Y-Site	Distronic Sterile Products, Inc.	FPA	Class II	1995-07-26
K946300	Dopplex Surgical Probes	Hne Healthcare, Inc.	ITX	Class II	1995-07-26
K945794	Duraphat	Inpharma A.S.	LBH	Class II	1995-07-26
K944872	Bio-Cor Collagen Corneal Shield	Bausch & Lomb Healthcare and Optics Worldwide	MOE	Class I	1995-07-26
K952845	Humid-Vent Trach-Vent	Gibeck, Inc.	BYD	Class I	1995-07-25
K952696	Xenon Light Source Model 5121	Richard Wolf Medical Instruments Corp.	GCT	Class II	1995-07-25
K952563	The Tulip Lci-200 Illumination & Imaging System	The Tulip Mfg. Co.	GCT	Class II	1995-07-25
K952288	Sas Salmonella H C Antiserum	SA Scientific, Ltd	GRM	Class II	1995-07-25
K952187	Rusch Supraflex Suprapubic Cystostomy Catheter Kit, Sterile	Rusch, Inc.	KOB	Class II	1995-07-25
K951984	White Knight Surgeon's Vest	White Knight Healthcare	FYA	Class II	1995-07-25
K951693	Caress Sanitary Napkin	Sterling U.S.A., Inc.	HHD	Class I	1995-07-25
K951658	Lactosorb Pop Rivet	Poly-Medics,Inc.	JDR	Class II	1995-07-25
K951172	Titanium Low Profile Cross Bar	Advanced Spine Fixation Systems, Inc.	MNH	Class II	1995-07-25
K950968	Tetrafilcon a Hydrophilic Contact Lenses	CooperVision, Inc.	LPL	Class II	1995-07-25
K950813	Mollring Cutter	Cardio Vascular Concepts, Inc.	DWX	Class II	1995-07-25
K950780	Amsino Cervical Scraper	Amsino Intl., Inc.	HHT	Class II	1995-07-25
K950179	Medtronic(r) Gc III Coronary Guiding Catheter	Medtronics Interventional Vascular	DQY	Class II	1995-07-25
K946047	Holgrath Metal-Hub, Epidural Needle	Holgrath Medical Technologies, Inc.	BSP	Class II	1995-07-25
K945949	Kilejian Circumcision Template [the Dome]	Vlm Surgical, Inc.	HFX	Class II	1995-07-25
K944450	Surgi-Link Lletz Needle Electrode, Loop Electrode, Square Loop Electrode	Unimed Surgical Products, Inc.	HGI	Class II	1995-07-25
K944270	Cit Monopolar Laparoscopic Instrments	Chirurgische Instrumente	HET	Class II	1995-07-25
K944034	Perio-Med Dental Floss	Whitehill Oral Technologies, Inc.	JES	Class I	1995-07-25
K943917	Capiox Arterial Filter	Terumo Medical Corp.	DTM	Class II	1995-07-25
K943308	Model 510 Infant Monitor	GE Medical Systems Information Technologies, Inc.	BZQ	Class II	1995-07-25
K941206	Dual Valve Aspiration/lavage Cannula and Aspiration/suction Probe	New Eder Corp.	HET	Class II	1995-07-25
K953161	Maico Ma630d Audiometer with Optional Reflex Decay & Eustachian Tube Function	Maico Hearing Instruments, Inc.	ETY	Class II	1995-07-24
K952947	Delpore Skin Closure	Bitco Intl.	FPX	Class I	1995-07-24
K952774	Multidex Gel	Lange Medical Products, Inc.	MGQ	Unclassified	1995-07-24
K952530	Head/neck Vascular Phased Array Coil Package	Philips North America LLC	LNH	Class II	1995-07-24
K952210	Lorad Steroloc II	Lorad Corp.	IZH	Class II	1995-07-24
K952033	Imagyn Hysteroscope	Imagyn Medical, Inc.	HIH	Class II	1995-07-24
K951389	Reunion Bone Screw System	Smith & Nephew Richards, Inc.	HWC	Class II	1995-07-24
K951071	Alko Slope Thb Solution for Corning 280, 288 and 2500 Analyzers	Alko Diagnostic Corp.	KRZ	Class II	1995-07-24
K950914	Ri-Former Wall Model 2,5 V/220 V or 110 V 3,5 V/220 V or 110 V, Ri-Former Anaesthetic Model 2,5 V/220 V or 110 C 3,5 V/v	Rudolf Riester GmbH & Co. KG	HLJ	Class II	1995-07-24
K950498	Life Trace Trans Tip Intrauterine Pressure Catheter	Graphic Controls Corp.	KXO	Class II	1995-07-24
K944669	Flexiflo Quantum Enteral Pump	Abbott Mfg., Inc.	FRN	Class II	1995-07-24
K953038	Dynamic Eq/class D	Midwest City Hearing Aid Center	ESD	Class I	1995-07-21
K953036	Db Push-Pull Hearing Aid	Midwest City Hearing Aid Center	ESD	Class I	1995-07-21
K952821	Mwchac 95 Fs 12345	Midwest City Hearing Aid Center	ESD	Class I	1995-07-21
K952820	Mwchac 95 C 12345	Midwest City Hearing Aid Center	ESD	Class I	1995-07-21
K952548	Celsite Venous System	B.Braun Medical, Inc.	LJT	Class II	1995-07-21
K952397	Vitalock Solid Backed Acetabular Shell	Howmedica Corp.	LPH	Class II	1995-07-21
K952146	Sas Brucellas Abortus Antiserum	SA Scientific, Ltd	GSM	Class II	1995-07-21
K952144	Sas Brucella Suis Antiserum	SA Scientific, Ltd	GSM	Class II	1995-07-21
K952143	Sas Brucella Melitensis Antiserum	SA Scientific, Ltd	GSM	Class II	1995-07-21
K952141	Sas Francisella Tularensis Antiserum	SA Scientific, Ltd	GSK	Class II	1995-07-21
K952134	Sas Salmonella H Poly Positive Antiserum	SA Scientific, Ltd	GRM	Class II	1995-07-21