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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2816 of 3530

510(k) clearances, page 2816 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K871909	Composite Restorative Carrier	Dentsply Intl.	EIY	Class I	1987-05-27
K871784	Top Form II Trays, Dispos Foam-Lined Top Gel Appli	Colgate-Hoyt Laboratories	KMT	Class I	1987-05-27
K871756	Creatinine Standard Solution Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-05-27
K871736	Carerite Biopack Gingival Retraction Cord	Cost Rite Health Products, Inc.	JES	Class I	1987-05-27
K871510	Modified Profile Hip Pmma Cement Spacer	Depuy, Inc.	JDI	Class II	1987-05-27
K871322	Advanced Medical Systems, Kit	The Jarid Group, Inc.	LRO	Class II	1987-05-27
K871281	IV Start Kit	The Jarid Group, Inc.	LRS	Class II	1987-05-27
K870843	Schultz Phalangeal Comp Trial/metacarpal Comp Tria	Warsaw Orthopedic, Inc.	HWT	Class I	1987-05-27
K870842	Schultz Phalangeal Comp Rasp/metacarpal Comp Rasp	Warsaw Orthopedic, Inc.	HTP	Class I	1987-05-27
K870805	Model 840 Transcutan. Oxygen/carbon Diox. Monitor	Novametrix Medical Systems, Inc.	KLK	Class II	1987-05-27
K870765	Cannulated Instrument Cleaners	Treace Medical, Inc.	EKW	Class I	1987-05-27
K870412	Triple Lumen Infusion Catheterization Set or Kit	Medical Surgical Concepts, Inc.	DQY	Class II	1987-05-27
K863969	Camino Compartmental Press Monitor Cath/110-4D	Camino Laboratories, Inc.	DXO	Class II	1987-05-27
K871874	Ciba Corning Magic Lite Analyzer II	Ciba Corning Diagnostics Corp.	JJQ	Class I	1987-05-26
K871855	Sorbitol Macconkey (Smac) Agar, Dri & Pre-Form	Gibco Laboratories Life Technologies, Inc.	JSH	Class I	1987-05-26
K871840	Mcconnell Orthopedic Ankle Positioner	Mcconnell Orthopedic	FWZ	Class I	1987-05-26
K871839	Mcconnell Orthopedic Pelvic Caliper Support	Mcconnell Orthopedic	FWZ	Class I	1987-05-26
K871838	Biomek 1000C Automated Laboratory Work Station	Beckman Instruments, Inc.	JJG	Class I	1987-05-26
K871824	Mcconnell Orthopedic Suspension System	Mcconnell Orthopedic	FWZ	Class I	1987-05-26
K871823	Mcconnell Orthopedic Tibial Positioner	Mcconnell Orthopedic	FWZ	Class I	1987-05-26
K871822	Mcconnell Orthopedic U-Hook Assembly	Mcconnell Orthopedic	FWZ	Class I	1987-05-26
K871821	Mcconnell Orthopedic Posterior Body Support	Mcconnell Orthopedic	FWZ	Class I	1987-05-26
K871820	Mcconnell Orthopedic Anterior Torso-Arm Support	Mcconnell Orthopedic	FWZ	Class I	1987-05-26
K871811	System Reagents Hitachi 737 Calcium (Edta)	Boehringer Mannheim Corp.	CIC	Class II	1987-05-26
K871782	Ultraviolet Alanine Amino-Trans (UV-Alt/uv-Gpt)	Biochemical Trade, Inc.	CKA	Class I	1987-05-26
K871768	Uric Acid Standard Solution Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-05-26
K871767	Urea N Standard Solution Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-05-26
K871766	Triglyceride Standard Solution Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-05-26
K871765	Phospholipids Standard Solution Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-05-26
K871764	Inorganic Phosphorous Standard Solution Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-05-26
K871763	Nefa Standard Solution Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-05-26
K871762	Magnesium Standard Solution Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-05-26
K871758	Glucose Standard Solution Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-05-26
K871714	Kestrel Contact Lens Case	Applied Laboratories, Inc.	LPN	Class II	1987-05-26
K871630	Kits and Trays for Dialysis Use	Dove Medical Supplies	FKG	Class I	1987-05-26
K871505	Autopak Neonatal Tsh Monoclonal Irma Kit	Micromedic Systems	JLW	Class II	1987-05-26
K871385	Model U-1000 with Gestational Age Calculation	Fukuda Denshi USA, Inc.	HGM	Class II	1987-05-26
K871307	Syva Q-Spec Photometer	Syva Co.	JJQ	Class I	1987-05-26
K871203	Bed Patient Presence Monitor	Human Technologies, Inc.	KMI	Class I	1987-05-26
K871150	Astra(tm) Systems Triglycerides Calibrator 8	Beckman Instruments, Inc.	JIT	Class II	1987-05-26
K871008	Micromedic Neonatal T4 Kit	Micromedic Systems	CDX	Class II	1987-05-26
K870998	Technicon Ra-Xt(tm) System Immunoassays	Technicon Instruments Corp.	JJC	Class I	1987-05-26
K870987	Ciba Corning Magic(r) Lite Ckmb Immunoassay	Ciba Corning Diagnostics Corp.	JHX	Class II	1987-05-26
K870971	Model 20-C with an Sa-20B/u Optical Attachment	Directed Energy, Inc.	GEX	Class II	1987-05-26
K870970	Model 10-C with an Sa-10B/u Optical Attachment	Directed Energy, Inc.	GEX	Class II	1987-05-26
K870904	Micromedic Neonatal Tsh Monoclonal Irma Kit	Micromedic Systems	JLW	Class II	1987-05-26
K870838	Model 10-C W/ Sa-10A/u Optical Attachment/surg Use	Directed Energy, Inc.	GEX	Class II	1987-05-26
K870837	Model 20-C W/sa-20A/u Optical Attachment/surg Use	Directed Energy, Inc.	GEX	Class II	1987-05-26
K870733	Colorgene DNA Hybridization Test for Hsv Confirma.	Enzo Biochem, Inc.	GQN	Class II	1987-05-26
K870730	Noiles Total Knee Prosthesis	Joint Medical Products Corp.	JWH	Class II	1987-05-26