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 2957 of 3529

510(k) clearances, page 2957 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853033	Hartshill Rect & Wires, Spinal Fixation System	A.W. Showell (Surgicraft), Ltd.	KWQ	Class II	1985-09-24
K852864	Gentle Lift-Recliner Chair	Pride Health Care Equipment	INO	Class II	1985-09-24
K852529	Hessburg Glide Untraocular Lens Guides	Visitec Co.	HQF	Class II	1985-09-24
K853638	Rionet Hearing Aid	Rion Acoustic Instruments, Inc.	ESD	Class I	1985-09-23
K853637	Rionet Hearing Aid Hi-07	Rion Acoustic Instruments, Inc.	ESD	Class I	1985-09-23
K853636	Rionet Hearing Aid Hi-06	Rion Acoustic Instruments, Inc.	ESD	Class I	1985-09-23
K853606	Personal Amplifier Communicator Premium	Electone, Inc.	ESD	Class I	1985-09-23
K853597	Instrument Makar Disposalbe Loop	Instrument Makar, Inc.	KDC	Class I	1985-09-23
K853527	Jufrey Corp. Univ. Dispos. Scalp Vein Infusion Set	Jufrey Multimed Corp.	FPA	Class II	1985-09-23
K853325	Dahlberg Ec Behind-the-Ear Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1985-09-23
K853324	Dahlberg Eb Behing-the-Ear Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1985-09-23
K853323	Dahlberg Ea Behing-the-Ear Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1985-09-23
K853264	Hearing Aid Model 337D	Telex Communications, Inc.	ESD	Class I	1985-09-23
K853220	Heartech Model Illusion	Hearing Tech, Inc.	ESD	Class I	1985-09-23
K853219	Heartech Model Ch	Hearing Tech, Inc.	ESD	Class I	1985-09-23
K853218	Heartech Model(htc) (Heritage)	Hearing Tech, Inc.	ESD	Class I	1985-09-23
K852802	Denar Dental Implant	Denar Corp.	DZE	Class II	1985-09-23
K852765	Ha-2000 Hydroxylapatite	Orthomatrix, Inc.	LYC	Class II	1985-09-23
K852755	Univar Universal Dentin Varnish	Scientific Pharmaceuticals, Inc.	LBH	Class II	1985-09-23
K852741	Dura Conditioner	Reliance Dental Mfg., LLC	EBI	Class II	1985-09-23
K852682	Calcitite Bone Graft Mat/oral & Maxillofacial Surg	Calcitek, Inc.	LYC	Class II	1985-09-23
K852612	Metronic Model F7700 Heart Valve Sizers	Medtronic, Inc.	DTI	Class I	1985-09-23
K851526	Convex Probe, Pve-393M	Toshiba Medical Systems	ITX	Class II	1985-09-23
K851524	Septoject Sterile Disposable Injection Needle	Specialites Septodont	DZM	Class I	1985-09-23
K851515	Heraenium Ca	Heraeus Dental Gold Corp.	EJH	Class II	1985-09-23
K851240	Sonolayer-L Sal-32B	Toshiba Medical Systems	ITX	Class II	1985-09-23
K853543	Davol Retrieval Balloon Catheter	C.R. Bard Inc	FGE	Class II	1985-09-20
K853418	Safti-Bracelet	Advanced Biosearch Assn.	KMK	Class I	1985-09-20
K853355	N.k. Pediatric Cribs	N.K. Medical Products, Inc.	FMS	Class II	1985-09-20
K852990	Pao Value	Ackard Laboratories	FMF	Class II	1985-09-20
K852893	Vial Decanter	Advance Medical Designs Inc	KPE	Class II	1985-09-20
K852819	Sterile Disposable Syringe(3 Pieces)	Fabersanitas, S.A.	FMF	Class II	1985-09-20
K852764	Idecap Dialyzer	Trans-National Trade Development Corp.	FJH	Class II	1985-09-20
K852613	Mic-Concept System	Microtech Medical Systems, Inc.	LTW	Class II	1985-09-20
K852543	Kontron Sigma Isc Echocardiograph System	Kontron Instruments, Inc.	DXK	Class II	1985-09-20
K852442	Pharma-Plast Needle	Pharma-Plast USA, Inc.	FMI	Class II	1985-09-20
K852304	Safe-N-Ject	Gerstner Intl. Trade	FMF	Class II	1985-09-20
K852084	Kendall Curity 100% Silicone Foley Catheter W/temp	The Kendal Co.	KOD	Class II	1985-09-20
K852083	The Kendall Urinary Output Monitor	The Kendal Co.	FFO	Class I	1985-09-20
K851301	Target Cat#b7850aa & B7850ab & B7850b	General Electric Co.	LHN	Class II	1985-09-20
K850416	Tomomatic 564	M.I.D., Inc.	KPS	Class II	1985-09-20
K842422	Kontron Fax Fetal Monitor	Kontron Instruments, Inc.	HGM	Class II	1985-09-20
K853776	Msi-Hb Hemoglobin Control	Medical Specialties Inc.	JPK	Class II	1985-09-19
K853745	Mic-Concept Viewbox	Microtech Medical Systems, Inc.	LIB	Class I	1985-09-19
K853682	Mount Tube Radiographic	X-Ray Systems	IYB	Class I	1985-09-19
K853655	New Jersey Modular Femoral Hip	Depuy, Inc.	JDI	Class II	1985-09-19
K853650	Auto Suture Titanium Hemostatic Clip	United States Surgical, A Division of Tyco Healthc	FZP	Class II	1985-09-19
K853647	Nitto Surgical Paper Tape St-310	Nitto Denko America, Inc.	KGX	Class I	1985-09-19
K853646	Nitto Surgical Non-Woven Tape St-320	Nitto Denko America, Inc.	KGX	Class I	1985-09-19
K853645	Nitto Surgical Cloth Tape St-330	Nitto Denko America, Inc.	KGX	Class I	1985-09-19