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 1922 of 3531

510(k) clearances, page 1922 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K965099	Accumeter H. Pylori Test	Chemtrak, Inc.	LYR	Class I	1997-02-20
K965064	Rostam Applicator Tampon/rostam Non Applicator Tampon	Rostam, Ltd.	HEB	Class II	1997-02-20
K965036	The Advanced Osmometer (3900)	Advanced Instruments, LLC	JJM	Class I	1997-02-20
K964982	Vitros Immunodiagnostics Products Lh Reagent Pack (Gem.1055) and Lh Calibrators (Gem.co55)	Johnson & Johnson Clinical Diagnostics, Inc.	CEP	Class I	1997-02-20
K964963	Lyphochek Coagulation Control	Bio-Rad	GGN	Class II	1997-02-20
K964913	Iron Reagent	Derma Media Lab., Inc.	JIY	Class I	1997-02-20
K964696	Sunsoft (Methafilcon a) Soft (Hydrophilic) Daily Wear Contact Lens	Sunsoft Corp.	LPL	Class II	1997-02-20
K964633	Accupack Pregnancy Test	Genix Biotek, Inc.	JHI	Class II	1997-02-20
K964452	Hematachek	Richmond Diagnostics, Inc.	GLK	Class II	1997-02-20
K964061	Gore Angioscopic Valvvlotome Kit (Tbd)	W. L. Gore & Associates, Inc.	LYK	Class II	1997-02-20
K964037	Flexible Cystoscope	Applied Fiberoptics, Inc.	FAJ	Class II	1997-02-20
K963676	Precision G Blood Glucose Testing System	Medisense, Inc.	CGA	Class II	1997-02-20
K963544	Supreme II Meter	Chronimed, Inc.	CGA	Class II	1997-02-20
K963207	Quickpac II One Step Marijuana (Thc) Test	Drial Consultants, Inc.	LDJ	Class II	1997-02-20
K963000	Maxi Ld Pta Balloon Catheter	Cordis US Corp.	LIT	Class II	1997-02-20
K962517	Model 7700 Quantum Pressure Support Ventilator Psv	Healthdyne Technologies, Inc.	MNS	Class II	1997-02-20
K962475	Orthopedic Perioperative Autotransfusion (Orthopat) System	Transfusion Technologies Corp.	CAC	Class II	1997-02-20
K944438	Hemagen Cmv Igg Kit	Hemagen Diagnostics, Inc.	LFZ	Class II	1997-02-20
K970346	Patient Specific Implant Hip Femoral Component	Kairos Orthopaedics	LZO	Class II	1997-02-19
K970110	Bard Flexible Endoscopy Injection System (651019)	Bard Medical Div.	ODC	Class II	1997-02-19
K965029	Stableloc II External Fixator	Acu Med, Inc.	JEC	Class II	1997-02-19
K964833	Rmi Dual Fluid Irrigating Syringe	Research Medical, Inc.	KYZ	Class I	1997-02-19
K964795	Cemented Calcar Replacement Femoral Stem	Johnson & Johnson Professionals, Inc.	JDI	Class II	1997-02-19
K964760	Dornier Medilas Fiber Tome Laser	Dornier Medtech America, Inc.	GEX	Class II	1997-02-19
K964665	Vascutek Gelweave Vascular Graft (Bifurcated Configuration)	Carbomedics, Inc.	DSY	Class II	1997-02-19
K964305	Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories	Nihon Kohden America Inc	CCK	Class II	1997-02-19
K962702	Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with Visualization and Cannula	General Surgical Innovations	GCJ	Class II	1997-02-19
K961073	Atlas 2.0 & Hitachi 2.0 (a Trade Name Subject to Change)	Atlantis Diagnostics Intl., Inc.	IYO	Class II	1997-02-19
K953978	Anterior Dynamized System	Acromed Corp.	KWQ	Class II	1997-02-19
K940942	Combison 530 Diagnostic Ultrasound Scanner	Medison America, Inc.	IYO	Class II	1997-02-19
K970389	Thyroid Calibrator	Dade Chemistry Systems, Inc.	JIT	Class II	1997-02-18
K970066	Unimed Coated Laparoscopic/arthroscopy/suction-Irrigation Electrode	Unimed Surgical Products, Inc.	GEI	Class II	1997-02-18
K970008	Advanced Quality Pregnancy Test	Bionike, Inc.	LCX	Class II	1997-02-18
K965253	Sas Pregnancy Strip	Sascie	JHI	Class II	1997-02-18
K965250	Sas Serum/urine Hcg	Sascie	JHI	Class II	1997-02-18
K965134	Alt/sgpt	Derma Media Lab., Inc.	CKA	Class I	1997-02-18
K965111	Stabilizer Soft Tissue Anchor Model Number Ta1005, Ta1008, Anchor Inserter/suture Organizer Model Numbers Ai1005, Ai1008	R. Thomas Grotz, M.D., Inc.	MBI	Class II	1997-02-18
K965109	Elecsys Estradiol Assay	Boehringer Mannheim Corp.	CHP	Class I	1997-02-18
K964960	Vitros Chemistry Products Upro Slides	Johnson & Johnson Clinical Diagnostics, Inc.	JGP	Class II	1997-02-18
K964857	Rapiseal Patch	Fusion Medical Technologies, Inc.	FTL	Class II	1997-02-18
K964668	Models Exl and Exs Extremity Coil Set	Mri Devices Corp.	MOS	Class II	1997-02-18
K964648	Protect All Blood Pressure Cuff Cover	Protect All, Inc.	DXQ	Class II	1997-02-18
K964486	Accucure 3000	Lasermed Corp.	GEX	Class II	1997-02-18
K963640	Olympus Acid Phosphatase Reagent	OLYMPUS Corporation of the Americas	CKB	Class II	1997-02-18
K961142	Stratec Lia II Analyzer	Nichols Institute Diagnostics	JJE	Class I	1997-02-18
K960363	Bipolar Shoulder Prosthesis-Shell(rd-113130/33, Biangular Modular Head(rd-113101/41/42,Biomodular Modular Head(rd-113143	Zimmer GmbH	MJT	Class III	1997-02-18
K955455	Baervelt Pars Plana Glaucoma Implant	Pharmacia Iovision, Inc.	KYF	Class II	1997-02-18
K970343	Mmb Method	Dade Chemistry Systems, Inc.	JHY	Class II	1997-02-14
K970311	Bentley Manually Operated Wheelchair	Pdg Product Design Group Inc	IOR	Class I	1997-02-14
K970225	Alpha Micron 20/40 Microaggregate Filter	Alpha Therapeutic Corp.	CAK	Class II	1997-02-14