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 2718 of 3530

510(k) clearances, page 2718 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882542	Lyphochek Unassayed Chemistry Control (Bovine)i/ii	Bio-Rad	JJY	Class I	1988-07-21
K882533	Latex Examination Glove	Sukas Export	FMC	Class I	1988-07-21
K882492	A.x.t. Spotfilm Device	Applied X-Ray Technologies, Inc.	IXL	Class II	1988-07-21
K882259	Dc-Bilitrol Catalogue # Se-021, Se-022, Se-023	Diagnostic Chemicals, Ltd. (USA)	JIT	Class II	1988-07-21
K881931	Rescue Mask & CPR Valve for Mouth-to-Mask Type CPR	Rondex Products, Inc.	CBP	Class II	1988-07-21
K881381	Reagents for Tsh Assay	Sclavo, Inc.	JLW	Class II	1988-07-21
K881284	Computerized Orthopaedic Pedotopography Machine	Nathaniel Gould Diagnostics, Inc.	JFC	Class I	1988-07-21
K881245	Dent-Ure Liner Soft Resilient Denture Lining Mater	Cadco Dental Products, Inc.	EBI	Class II	1988-07-21
K881142	Amerlite Fsh Assay, Lan.0077/2077 240 and 144 Test	Amersham Corp.	CGJ	Class I	1988-07-21
K881081	Dermapoints Model 200 Therapeutic Massager	Ferguson Medical	LYG	Class I	1988-07-21
K881080	Dermapoints Model 100 Therapeutic Massager	Ferguson Medical	LYG	Class I	1988-07-21
K882216	Syncor (R) Model S-801 ECG Electrode	Lectec Corp.	DRX	Class II	1988-07-20
K881940	Model 20 Ky Krypton Yellow Laser	Hgm Medical Laser Systems, Inc.	GEX	Class II	1988-07-20
K881720	Jimmy John III	Colon Therapeutics	KPL	Class II	1988-07-20
K881446	Ormon Digital Fever Thermometer Model Mc-3B	Ormon Electronics, Inc.	FLL	Class II	1988-07-20
K882790	Minimum Essential Medium Eagle, No. 200-2042	J R Scientific	KIT	Class I	1988-07-19
K882788	Minimum Essential Medium Eagle No. 200-2047	J R Scientific	KIT	Class I	1988-07-19
K882787	Dulbecco's Modified Eagle's Medium No. 200-2019	J R Scientific	KIT	Class I	1988-07-19
K882786	Rpmi-1640 Catalog No. 200-2079	J R Scientific	KIT	Class I	1988-07-19
K882785	Dulbecco's Modified Eagle's Medium No. 200-2006	J R Scientific	KIT	Class I	1988-07-19
K882784	Rpmi-1640 Catalog No. 200-2121	J R Scientific	KIT	Class I	1988-07-19
K882783	Basal Medium Eagle (Bme) Diploid, No. 200-2043	J R Scientific	KIT	Class I	1988-07-19
K882782	Rpmi-1640 Medium, Catalog No. 200-2081	J R Scientific	KIT	Class I	1988-07-19
K882781	Rpmi-1640 Medium, Catalog No. 200-2077	J R Scientific	KIT	Class I	1988-07-19
K882780	Nutrient Mixture F-10 (Ham), No. 200-2061	J R Scientific	KIT	Class I	1988-07-19
K882779	Basal Medium Eagle Catalog No. 200-2052	J R Scientific	KIT	Class I	1988-07-19
K882778	Basal Medium Eagel, Catalog No. 200-2044	J R Scientific	KIT	Class I	1988-07-19
K882777	Dulbecco's Modified Eagle's Medium, No. 200-2004	J R Scientific	KIT	Class I	1988-07-19
K882776	Dulbecco's Modified Eagle's Medium, No. 200-2014	J R Scientific	KIT	Class I	1988-07-19
K882775	Dulbecco's Modified Eagle's Medium, No. 200-2023	J R Scientific	KIT	Class I	1988-07-19
K882774	Dulbecco's Modified Eagle's Medium, No. 200-2002	J R Scientific	KIT	Class I	1988-07-19
K882493	Rod, Irrigator Supporting, Telescoping Type	Cambridge Technologies, Inc.	FOX	Class I	1988-07-19
K882332	Headrest, Patient Comfort	Surgic Aid, Inc.	KME	Class I	1988-07-19
K881982	Pca Modular Total Knee Sys-All Plas Patellar Comp	Howmedica Corp.	JWH	Class II	1988-07-19
K881921	C-E Brush	Surgipath Medical Industries, Inc.	HHT	Class II	1988-07-19
K881854	Sorbsan Topical Wound Dressing	E.G. Dick & Assoc.	FRO	Unclassified	1988-07-19
K874443	Ionodent (Toothbrush)	U.S. Apatite Corp.	EFW	Class I	1988-07-19
K874192	Multipurpose Transducer Range	Pie Data Medical BV	IYO	Class II	1988-07-19
K882808	Rpmi-1640 Medium, Catalog No. 200-2076	J R Scientific	KIT	Class I	1988-07-18
K882807	Dulbecco's Modified Eagle's Medium No. 200-2011	J R Scientific	KIT	Class I	1988-07-18
K882806	Medium 199, Catalog No. 200-2032	J R Scientific	KIT	Class I	1988-07-18
K882798	Multiflo Adapter	Deseret Medical, Inc.	FPA	Class II	1988-07-18
K882797	Luer-Lok Multiflo Adapter	Deseret Medical, Inc.	FPA	Class II	1988-07-18
K882793	Pmt Fukushima Microsurgical Instrument Line	PMT Corp.	GAF	Class I	1988-07-18
K882789	Coon's Medium F-12, Catalog No. 200-2066	J R Scientific	KIT	Class I	1988-07-18
K882773	Mccoy's 5A Medium, Cata No. 200-2026	J R Scientific	KIT	Class I	1988-07-18
K882767	Sysmex Dd-100 Whole Blood Dilution System	Toa Medical Electronics USA, Inc.	GKH	Class I	1988-07-18
K882742	Fiber Optic Light Source Cat. #E9100	Medtronic, Inc.	GEI	Class II	1988-07-18
K882646	Lectrobrasive(r) E2401	Medtronic, Inc.	GEI	Class II	1988-07-18
K882613	Alm Surgical Lamps	Alm Surgical Equipment, Inc.	FTD	Class II	1988-07-18