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 2129 of 3531

510(k) clearances, page 2129 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945718	Document(r) Hdl Cholesterol Calibration Verification Test Set	Casco Standards	JJX	Class I	1995-01-17
K945640	Ri-Scope S Otoscope	Rudolf Riester GmbH & Co. KG	HLJ	Class II	1995-01-17
K945568	Hcg Midstream Pregnancy Test	Mizuho USA, Inc.	LCX	Class II	1995-01-17
K945378	Pulpdent Chemical Cure Pit and Fissure Sealant	Pulpdent Corporation	EBC	Class II	1995-01-17
K945345	Cedia Dau Cocaine Assay	Microgenics Corporation	DIO	Class II	1995-01-17
K945343	Cedia Dau Opiate Assay	Microgenics Corporation	DJG	Class II	1995-01-17
K945338	Theophylline Calibrators	Diagnostic Reagents, Inc.	DLJ	Class II	1995-01-17
K945172	Visitec Silicone Retinal Implants/explants	Visitec Co.	HQX	Class II	1995-01-17
K944785	Sas Quant Hcg Serum	SA Scientific, Ltd	JJX	Class I	1995-01-17
K944455	Quantitate Electrolyte Verifier Set (Serum Range)	Beckman Instruments, Inc.	JJY	Class I	1995-01-17
K944454	Quanititate Gbcc Verifier Set	Beckman Instruments, Inc.	JJY	Class I	1995-01-17
K943432	Hemocue B-Glucose System	HemoCue AB	CGA	Class II	1995-01-17
K943091	Easy Lyte Calcium Analyzer	Medica Corp.	JFP	Class II	1995-01-17
K942664	Kendall Model 6325 Scd Sequel Compression System	The Kendal Co.	JOW	Class II	1995-01-17
K942661	Aqualite Tsh Bioluminescent Immunoassay Kit	Sealite Sciences, Inc.	JLW	Class II	1995-01-17
K942298	The Karl Storz Arthropump	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1995-01-17
K941906	Model 2730 Clinical Refractometer	Vee Gee Scientific, Inc.	JRE	Class I	1995-01-17
K941903	Model 2740 Clinical Refractometer	Vee Gee Scientific, Inc.	JRE	Class I	1995-01-17
K941901	Model 2721 Clinical Refractometer	Vee Gee Scientific, Inc.	JRE	Class I	1995-01-17
K941755	Ortholoc Advantim Lsi Posterior Stablized All Polythylene Tibial Component	Wrightmedicaltechnologyinc	JWH	Class II	1995-01-17
K941166	Quest Coronary Sinus Perfusion Cannula	Quest Medical, Inc	DWF	Class II	1995-01-17
K940215	Glucochek	Clinical Diagnostics, Inc.	CGA	Class II	1995-01-17
K935851	Biomerieux Hemolab Cofac X	Biomerieux Vitek, Inc.	GJT	Class II	1995-01-17
K935850	Biomerieux Hemolab Cofac VII	Biomerieux Vitek, Inc.	GJT	Class II	1995-01-17
K933610	Exactech Cemented Total Knee System, Tibial Components	Exactech, Inc.	JWH	Class II	1995-01-17
K945816	Quick-Lock	B & B Medical Technologies, Inc.	BTR	Class II	1995-01-13
K945593	Scimed(r) Coronary Guide Wire Exchange/infusion Catheter	Scimed Life Systems, Inc.	KRA	Class II	1995-01-13
K945565	Spiro-Flex	Inhalation Plastics, Inc.	CAI	Class I	1995-01-13
K945513	Mallinckrodt Shiley Neonatal, Pediatric, Long Pediatric Tracheostomy Tube	Mallinckrodt Medical	JOH	Class II	1995-01-13
K945154	Ba-Cpas	Nobelpharma USA, Inc.	FZE	Class II	1995-01-13
K945118	Expiratory Breathing Exerciser	Dhd Diemolding Healthcare Div.	BWF	Class II	1995-01-13
K945110	Kolberg Ophthalmic Conformer	Kolberg Ocular Products, Inc.	HQN	Class II	1995-01-13
K945070	Versasae Plastic Cannula- 11 Gauge	Imed Corp.	FPA	Class II	1995-01-13
K945040	Hamid Hook Attachment Device for Hemilaminectomy Retractor	Hamid M. Mehdizadeh, M.D.	GZT	Class II	1995-01-13
K941551	The Vanguard System	Cleveland Clinic Foundation	GWQ	Class II	1995-01-13
K935749	Road Warrior	Redman, Inc.	ITI	Class II	1995-01-13
K946321	Biostrip Sterile Wound Closure Strip	Cornelia Damsky, Inc.	FPX	Class I	1995-01-12
K946269	Curafoam Andd Curafoam Plus Hydrophilic Polyurethane Foam Dressings	Kendall Healthcare Products Co. Div.Of Tyco Health	KMF	Class I	1995-01-12
K945988	Sunglasses	R.J. Standard Corp.	HQY	Class I	1995-01-12
K945960	Lorrex Non-Woven Sponges Non-Sterile, Sterile, Dressings	Lorons International Corp.	EFQ	Unclassified	1995-01-12
K945917	Powerr Rangers Sunglasses	Dollar Land Stores, Inc.	HQY	Class I	1995-01-12
K945545	Access Surgical Int'l Thoracic Endoscopic Surgical Instruments	Access Surgical Intl., Inc.	GCJ	Class II	1995-01-12
K945313	Sparta Hydrogel Wound Dressing	Sparta Surgical Corp.	MGQ	Unclassified	1995-01-12
K945206	Alldress Multi Layered Wound Dressing	Scott Health Care	KMF	Class I	1995-01-12
K945192	Hair Removal System	L.P. Systems Corp.	KCW	Class I	1995-01-12
K945144	Sponge Count	Michael Fischer Assoc.	LWH	Class I	1995-01-12
K944882	Irrigation Tray	Clinical Resources, Inc.	EYN	Class II	1995-01-12
K944601	Zimmer Zirconia Ceramic Femoral Head	Zimmer GmbH	LZO	Class II	1995-01-12
K944156	Heine Lambda 100	Heine USA, Ltd.	HOX	Class I	1995-01-12
K943928	Apilus Electropil	Dectro Intl., Inc.	KCW	Class I	1995-01-12