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 2806 of 3530

510(k) clearances, page 2806 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872389	Precision Screw Driver Set	Med-Tool, Inc.	HXX	Class I	1987-07-15
K872357	Transworld 360V, Model A1-4040	Transworld X-Ray Corp.	IZO	Class I	1987-07-15
K872312	Model 3000 Ophthalmic Surgical System	Allergan Humphrey	HQE	Class II	1987-07-15
K872045	Conductivity Gel	Futuremed Div. of Future Impex Corp.	GYB	Class II	1987-07-15
K871913	Conductivity Gel	Futuremed Div. of Future Impex Corp.	GYB	Class II	1987-07-15
K871700	Hcg Mab Solid Phase Component System	BD Becton Dickinson Vacutainer Systems Preanalytic	JHI	Class II	1987-07-15
K871609	Ultrasound Transducer Sheaths, Sterile	Amedic USA	ITX	Class II	1987-07-15
K871577	Htf Medium and Modified Htf Medium-Hepes	Irvine Scientific LLC	HDR	Class II	1987-07-15
K871565	Ultrasound Transducer Gel, Sterile	Amedic USA	JOT	Class II	1987-07-15
K872261	Tampax Deodorant Tampon, Super	Tambrands Inc.	HIL	Class II	1987-07-14
K872069	Kontour Ultra Soft Sponge #Ss144.50	Winfield Laboratories, Inc.	NAD	Class I	1987-07-14
K871413	Civco Stepper	CIVCO Medical Instruments Co., Inc.	FZX	Class I	1987-07-14
K870999	Gender Choice Information Kit, Female and Male	Procare C/O Wiley, Rein & Fielding	LHD	Unclassified	1987-07-14
K872011	Port Access Kits	The Jarid Group, Inc.	LRO	Class II	1987-07-13
K871723	Sweet Vernal Allergen Disc	Incstar Corp.	DHB	Class II	1987-07-13
K871453	Zweymueller-Sl Hip Prosthesis Stem	Allo Pro Corp.	KWA	Class III	1987-07-13
K871079	Fetalflex Fetal Electrode	Epcom Medical Systems, Inc.	HGP	Class II	1987-07-13
K872555	Hearing Aid 47 Series	Electone, Inc.	ESD	Class I	1987-07-10
K872538	Vitapatch Pin Protection Device for Percut. Pins	Vitaphore Corp.	JEC	Class II	1987-07-10
K872260	Tampax Deodorant Tampon, Slender Regular	Tambrands Inc.	HIL	Class II	1987-07-10
K872259	Tampax Petal Soft Deodorant Tampon, Super	Tambrands Inc.	HIL	Class II	1987-07-10
K872258	Tampax Petal Soft Deodorant Tampon, Super Plus	Tambrands Inc.	HIL	Class II	1987-07-10
K872257	Tampax Petal Soft Deodorant Tampon, Regular	Tambrands Inc.	HIL	Class II	1987-07-10
K872256	Tampax Deodorant Tampon, Original Regular	Tambrands Inc.	HIL	Class II	1987-07-10
K872255	Tampax Deodorant Tampon, Super Plus	Tambrands Inc.	HIL	Class II	1987-07-10
K872242	Type 6400 Real Ear Hearing Aid Analyzer	Frye Electronics, Inc.	ETW	Class II	1987-07-10
K872215	Perio-Test	Dr. Bernard Loewenthal	EIL	Class I	1987-07-10
K872212	Hearing Aid (All-in-the-Ear)	Marketing Specialist, Inc.	ESD	Class I	1987-07-10
K871960	Electro-Gyne Electrosurgical Generator	Cabot Medical Corp.	KNF	Class II	1987-07-10
K871863	Adbutment Cylinder and Screw	Implant Innovations International, Inc.	DZE	Class II	1987-07-10
K871862	Post. Screw & Hex Driver/adbut & Adbut Head Driver	Implant Innovations International, Inc.	DZE	Class II	1987-07-10
K871745	Model 26021C Bipolar Coagulator	Karl Storz Endoscopy-America, Inc.	HIN	Class II	1987-07-10
K871503	Biopsy Needle Guide Kit, Sterile	Amedic USA	FZX	Class I	1987-07-10
K870773	Endocoagulator Models 5, 8 & 20 Argon Laser	Hgm, Inc.	LLF	Class III	1987-07-10
K864807	Teknar Proscan(tm)	Teknar, Inc.	IYO	Class II	1987-07-10
K862511	Tomomatic 232	Medimatic S.r.l.	KPS	Class II	1987-07-10
K872507	Precision Culture C.a.t.s. Collect/trans Hsv i/ii	Precision Dynamics Corporation	JSM	Class I	1987-07-09
K872500	Anatech Hematoxylin-Extra Strength	Anatech, Ltd.	HYJ	Class I	1987-07-09
K872499	Anatech Hematoxylin-Normal Strength	Anatech, Ltd.	HYJ	Class I	1987-07-09
K872498	Harris Hematoxylin	Anatech, Ltd.	HYK	Class I	1987-07-09
K872494	Hitachi 717 Chemistry Analyzer	Boehringer Mannheim Corp.	JJE	Class I	1987-07-09
K872465	Dulbecco's Modified Eagle's Medium (Dme)	J R Scientific	KIT	Class I	1987-07-09
K872377	Chrom-Trol	Helena Laboratories, Corp.	JPA	Class II	1987-07-09
K872330	Emds Salicylate (Sal) Testpacks, Item No. 67694/95	Em Diagnostic Systems, Inc.	DKJ	Class II	1987-07-09
K872311	Abbott a-Gent Liquid Magnesium Reagent	Abbott Medical	JGJ	Class I	1987-07-09
K872237	Kallestad Qm300 Igm Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DFT	Class II	1987-07-09
K871977	Dade Moni-Trol Chemistry Control/calibrator	American Dade	JJY	Class I	1987-07-09
K871873	Closed Chest Drainage Set	Gish Biomedical, Inc.	LRO	Class II	1987-07-09
K871583	Modified Labeling for Amukin-50%	Amuchina Intl., Inc.	KDJ	Class II	1987-07-09
K871516	Sl-100 Nd:yag Laser for Urologic Surgery	Medical Energy, Inc.	LNK	Class II	1987-07-09