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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2882 of 3529

510(k) clearances, page 2882 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862874	The Towered 90/90 Unit	Lossing Orthopedic, Inc.	HST	Class I	1986-08-07
K862857	Franklin Chairs/moves, #4000 Series & #4100 Series	Franklin Corp.	INO	Class II	1986-08-07
K862846	Tec Vari-Trac II Traction Unit	Therapeutic Equipment Corp.	ITH	Class II	1986-08-07
K862801	Spunguard Plus Surgical Drape	Kimberly-Clark Corporation	KKX	Class II	1986-08-07
K862767	Silicone Sump Drain	Sil-Med Corp.	GBS	Class I	1986-08-07
K862752	C.s.m. Hip	Protek, Inc.			1986-08-07
K862628	Bunn Model 510 Medication Compressor	The John Bunn Co.	BTI	Class II	1986-08-07
K862623	I81 Initiales	Oticon, Inc.	ESD	Class I	1986-08-07
K862534	Paulus Titanium Mini Bone Plates & Bone Screws	Biomet Microfixation	JEY	Class II	1986-08-07
K862505	Manual Surg. Instru. for Paulus Titanium System	Biomet Microfixation	JEY	Class II	1986-08-07
K862504	Ace Mos Saw and the Ace Mos Spine Saw	Buckman Co., Inc.	JDX	Class II	1986-08-07
K862236	Myolab II, Model Ml-200	Motion Control, Inc.	IKN	Class II	1986-08-07
K862110	Osseodent Drilling System	Otc/America	KMW	Class II	1986-08-07
K861837	Fischer/krystal Therapeutic Ultrasound	Fischer Industries, Inc.	IMG	Class II	1986-08-07
K861826	Kirschner Proximal Femur Total Hip System	Kirschner Medical Corp.			1986-08-07
K861646	Bio-Carb D16000, D16001, and D17000	Societe D' Analyses Bio-Pharmaceutiques,Inc.	FJH	Class II	1986-08-07
K861564	The Lung Gym (Xlator and Nlator)	El-Fax Company, Inc.	BWF	Class II	1986-08-07
K861450	Schurman/carter Hip Prosthesis Porous Coated	Kirschner Medical Corp.			1986-08-07
K861331	Endoscopic Electrosurgical Fiberoptic Probe	Trimedyne, Inc.	LNK	Class II	1986-08-07
K860847	Wallant Neurologix General Purpose TENS	Wallant Intl. Trade, Inc.	GZJ	Class II	1986-08-07
K860083	Dermascan Laser Surgical Handpiece	Medical Laser Research & Development Corp.	GEX	Class II	1986-08-07
K862853	Syringe Injection Gun	Gastrotech, Inc.			1986-08-06
K862771	Medcomp C.a.v.h. Catheter	Medical Components, Inc.	LFK	Class II	1986-08-06
K862765	Euromed S-601	Lectec Corp.	DRX	Class II	1986-08-06
K862756	Pregelled Infant Disposable ECG Electrode	Labeltape Meditect, Inc.	DXN	Class II	1986-08-06
K862746	Em Diagnostic ECG Electrode	Electromed Intl., Ltd.	DRX	Class II	1986-08-06
K862694	Floss Card	Floss Card Co.	JES	Class I	1986-08-06
K862655	Signa II Resting ECG Electrode	Kone Instruments, Inc.	DRX	Class II	1986-08-06
K862608	Spertilite Phototherapy Lamp	Cooper-Hewitt Electric Co.	FTC	Class II	1986-08-06
K862579	Tru-Trac 3-Dimensional Cervical Traction-Td-9000	Tru-Trac	ITH	Class II	1986-08-06
K862544	Kenz-ECG-102 Single Channel Electrocardiograph	Suzuken Co., Ltd.	DPS	Class II	1986-08-06
K862433	Uni-Jet Connector	Acutronic Medical Systems AG	BZA	Class I	1986-08-06
K862344	Gould Xcaliber	Bio-Tek Instruments, Inc.	DRS	Class II	1986-08-06
K862313	Kallestad Sm/rnp Test Reagent	Kallestad Laboratories, Inc.	LKJ	Class II	1986-08-06
K862174	Timothy Allergen Disc	Immuno Nuclear Corp.	DGC	Class II	1986-08-06
K862167	Mini-Trach Kit	Abbott Medical	BTO	Class II	1986-08-06
K861780	Coulter Counter Model S Plus Junior	Coulter Electronics, Inc.	GKL	Class II	1986-08-06
K861375	Model Mb-500 & Mb-600 Blood Pressure Monitors	Sharp Electronics Corp.	DXN	Class II	1986-08-06
K861364	Neoguard ECG Electrodes	Cas Medical Systems, Inc.	DXN	Class II	1986-08-06
K861338	Dental Cotton Rolls, Sterile and Non-Sterile	Intl. Verbandstoff-Fabrik Schaffhau	EFN	Class I	1986-08-06
K861246	Premie Disc ECG Electrode W/preattached Lead	Conmedcorp	DRX	Class II	1986-08-06
K861099	Gereonics Biopotential Skin Electrodes	Gereonics, Inc.	DRX	Class II	1986-08-06
K860738	Ctc 30, 40, 1 Liquid Oxygen Liters	Cryodyne Technologies, Inc.	BYJ	Class II	1986-08-06
K860207	S-Rom 135 Porous Coated Femoral Stem Collar	Joint Medical Products Corp.			1986-08-06
K862698	6000 Nd:yag Laser for Benign/malignant Obstruction	Cooper Lasersonics, Inc.	LLO	Class II	1986-08-05
K861984	Umi Cath-Seal, 13+14F & Transseptal Catheter Intro	Universal Medical Instrument Corp.	DYB	Class II	1986-08-05
K851064	Cordis Hi-Flex Pervenous Active Fixation Unipolar	Cordis US Corp.	DTB	Class III	1986-08-05
K832422	Cordis Ancor Active Fixation Lead	Cordis US Corp.	DTB	Class III	1986-08-05
K862780	Tru-Kinetics (Tm)	Tru-Trac	IKK	Class II	1986-08-04
K862761	Vacutainer Brand Agar Slant	BD Becton Dickinson Vacutainer Systems Preanalytic	KZI	Class I	1986-08-04