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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3180 of 3528

510(k) clearances, page 3180 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823915	Mirror Tip	Treace Medical, Inc.	KAI	Class I	1983-01-21
K823914	Explorer Tip	Treace Medical, Inc.	EKB	Class I	1983-01-21
K823911	Knife Blade Tip	Treace Medical, Inc.	JYO	Class I	1983-01-21
K823872	Emergency Tracheostomy Kit	Omnicon Medical Corp.	EWC	Class I	1983-01-21
K823847	Rionet Hearing Aid Hb-69Ci	Rion Acoustic Instruments, Inc.	ESD	Class I	1983-01-21
K823836	Monoject Samplette Capillary Blood Coll	Sherwood Medical Co.	JKA	Class II	1983-01-21
K823821	Side Rail Pads	Danek Medical, Inc.	FNJ	Class I	1983-01-21
K823803	Rionet Hearing Aid Hb-32P	Rion Acoustic Instruments, Inc.	ESD	Class I	1983-01-21
K823773	Provial II #006-010-0201	Dynatech Corp.	KDT	Class I	1983-01-21
K823761	Erythrocyte & Stand Sediment. Rate Tube	Cordis US Corp.	JPH	Class I	1983-01-21
K823742	Neuromod Complement #7724 Dual Channel	Medtronic, Inc.	GZJ	Class II	1983-01-21
K823729	Spectron Metal Back Acetabular Component	Richard'S Medical Equip., Inc.	JDI	Class II	1983-01-21
K823728	Spectron Polyethylene Acctubular Compon	Richard'S Medical Equip., Inc.	JDI	Class II	1983-01-21
K823725	Spectron Protrusio Cup	Richard'S Medical Equip., Inc.	JDI	Class II	1983-01-21
K823710	Disposable Airway Adejunct	Groves Medical Supply, Inc.	BTM	Class II	1983-01-21
K823683	Vitalograph Pft Printer	Vitalograph, Inc.	BTY	Class II	1983-01-21
K823657	Card Holder for Quads	Fred Sammons, Inc.	ILT	Class I	1983-01-21
K823656	Soft Catcher's Mitt	Fred Sammons, Inc.	ILT	Class I	1983-01-21
K823654	Slip-on Sandals for Measuring Shortness	Fred Sammons, Inc.	KNP	Class I	1983-01-21
K823650	Thermoelastomer Hot/cold Compress-7187-	Fred Sammons, Inc.	IME	Class I	1983-01-21
K823649	Thermoelastomer Hot/cold Compress Bk7186	Fred Sammons, Inc.	IME	Class I	1983-01-21
K823648	Surgical Tubing	Fred Sammons, Inc.	IOD	Class I	1983-01-21
K823647	Finger Extension Splint	Fred Sammons, Inc.	ILH	Class I	1983-01-21
K823646	Friction Feeder	Fred Sammons, Inc.	KNO	Class I	1983-01-21
K823645	Velcro Straps to Hold Arm to Wheelchair	Fred Sammons, Inc.	KNO	Class I	1983-01-21
K823644	Finger Flexion Splint	Fred Sammons, Inc.	ILH	Class I	1983-01-21
K823641	Bathing Chair for Child	Fred Sammons, Inc.	ILS	Class I	1983-01-21
K823640	Bath Tub Safety Bar	Fred Sammons, Inc.	IKX	Class I	1983-01-21
K823639	Board to Transfer Paralyzed Patient from	Fred Sammons, Inc.	IKX	Class I	1983-01-21
K823638	Arm Through for Wheelchair Bk 6454-01 &	Fred Sammons, Inc.	KNN	Class I	1983-01-21
K823637	Arm Through for Wheelchair Bk-6458-01	Fred Sammons, Inc.	KNN	Class I	1983-01-21
K823558	Micro-Hematocrit Centrifuge 335/336	Fisher Scientific Company L.L.C.	JPI	Class II	1983-01-21
K823501	Zee Sphygmomanometer	Zee Medical Products Co., Inc.	DXN	Class II	1983-01-21
K823495	Mobilimb-Cpm Upper/lower Limb Device	Synthes (USA) Products LLC	BXB	Class I	1983-01-21
K823453	Von Willebrand Factor Assay	General Diagnostics	GGP	Class II	1983-01-21
K823409	Heliosit-Orthodontic	Vivadent (USA), Inc.	DYH	Class II	1983-01-21
K823243	Sidearm Y-Adaptor	American Edwards Laboratories	DQO	Class II	1983-01-21
K823236	Back on Track Inversion Therapy & Exer	Lossing Orthopedic, Inc.	ION	Class I	1983-01-21
K823194	Skin Galvanometer	Spelson Research Laboratories, Inc.	HCJ	Class II	1983-01-21
K823089	Rci Earmate	Rci, Inc.	ESD	Class I	1983-01-21
K823085	Berkeley Chair	Berkeley Electric Wheelchair Co.	ITI	Class II	1983-01-21
K823069	Kf-E Series Hollow Fiber Dialyzer	Medisystems Corp.	KOC	Class II	1983-01-21
K822755	Latex Penrose Tubing	American Hospital Supply			1983-01-21
K823473	Porocoat Mark IV Elbow	Depuy, Inc.	JDB	Class II	1983-01-20
K828673	Rich-Mar Ultrasound Coupling Lotion	Whs Products, Inc.			1983-01-19
K828671	Uvatec Suntamed 4000 and 2000	Solitec GmbH			1983-01-19
K823763	Various-Specimen Collectors	Cordis US Corp.	FMH	Class I	1983-01-19
K830047	Fiber Optic Laryngoscopes W/battery	Welch Allyn Inc	CCW	Class I	1983-01-18
K830019	Amnio Centeses Kit W/needle	Universal Medical Instrument Corp.	HIO	Class I	1983-01-18
K823792	Quartz Retractor/probe	American V. Mueller	KOH	Class I	1983-01-18