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 2836 of 3529

510(k) clearances, page 2836 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K865049	Gdc 1824	Deringer-Ney, Inc.	EJT	Class II	1987-03-04
K865012	Ysi Model 801	Yellow Springs Instrument Co., Inc.	FMT	Class II	1987-03-04
K864933	'Exmoor' Shah & Mackay Nasal Splints	Exmoor Plastics Limited	EPP	Class I	1987-03-04
K864932	'Exmoor' Cawood Nasal Splints	Exmoor Plastics Limited	EPP	Class I	1987-03-04
K864930	'Exmoor' Atkins Nasal Splint	Exmoor Plastics Limited	EPP	Class I	1987-03-04
K864859	Super Petal Soft Plastic Applicator Tampax Tampons	Tambrands Inc.	HEB	Class II	1987-03-04
K864852	Vista Interface System	Vacumetrics, Inc.	BZL	Class II	1987-03-04
K864652	Super Plus Tampons	Tambrands Inc.	HEB	Class II	1987-03-04
K864651	Super Tampons	Tambrands Inc.	HEB	Class II	1987-03-04
K864650	Slender Regular Tampons	Tambrands Inc.	HEB	Class II	1987-03-04
K864649	Regular Petal Soft Plastic Applicator Tampons	Tambrands Inc.	HEB	Class II	1987-03-04
K864648	Super Plus Petal Soft Plastic Applicator Tampons	Tambrands Inc.	HEB	Class II	1987-03-04
K864613	502 Oxygen Saturation Monitor	Criticare Systems, Inc.	DQA	Class II	1987-03-04
K864518	Lacey Press-Fit Condylar Total Knee	Dow Corning Wright	JWH	Class II	1987-03-04
K864222	Series 620 Rectal Probe Cover	General Electric Co.	ITX	Class II	1987-03-04
K863166	Model 6110 Iontophoretic Applicator	Life-Tech Intl., Inc.	EGJ	Class II	1987-03-04
K862401	Personal/derby Condoms	Razi Corp.	HIS	Class II	1987-03-04
K870761	Ear Loop	Treace Medical, Inc.	JYQ	Class I	1987-03-03
K870756	Vein Graft Ear Scissors	Treace Medical, Inc.	JZB	Class I	1987-03-03
K870562	Daig Pacemaker Lead Adaptor	Daig Corp.	DTD	Class II	1987-03-03
K870394	Hydrophobic #6194418/Hydraphilic #6104418 Filters	Clinical Connections, Inc.	FIB	Class II	1987-03-03
K870323	Model Ev4543 Miniature Temporary Cardiac Pacemaker	Pace Medical	DTE	Class II	1987-03-03
K870163	Biochem Microspan 1040 Oximeter	Biochem International, Inc.	DQA	Class II	1987-03-03
K870081	Micro-Ear Low-Profile in-the-Ear Hearing Aid	Micro-Ear Hearing Center, Inc.	ESD	Class I	1987-03-03
K870080	Micro-Ear Full-Concha in-the-Ear Hearing Aid	Micro-Ear Hearing Center, Inc.	ESD	Class I	1987-03-03
K870079	Micro-Ear Canal in-the-Ear Hearing Aid	Micro-Ear Hearing Center, Inc.	ESD	Class I	1987-03-03
K870034	Model Py...u Unipolar & Bipolar Pacing Lead	Oscor Medical Corp.	DTB	Class III	1987-03-03
K865084	Amici Xenon Rebreathing System*	Amici, Inc.	IYT	Class II	1987-03-03
K865079	Aspirating Needle, Catalog Code #12006	Dlp, Inc.	DWF	Class II	1987-03-03
K864989	Etp 180A Non-Invasive External Pacemaker	Medac, Inc.	DRO	Class II	1987-03-03
K864988	Etp 180E Non-Invasive External Pacemaker	Medac, Inc.	DRO	Class II	1987-03-03
K864987	Dispos Gel External Pacing Electrode/hi Impedance	Medac, Inc.	DRO	Class II	1987-03-03
K864986	Etp 300 Non-Invasive External Pacemaker	Medac, Inc.	DRO	Class II	1987-03-03
K864587	Fresenius Ultraflux Av400, Av600	Seratronics, Inc.	KDI	Class II	1987-03-03
K864401	Plurimus Cardiac Evaluation System	Vivix Corp.	DSI	Class II	1987-03-03
K863783	Hzi Ceeg/ep System Software (Ceeg-Scan)tm	Hzi Research Center	OLT	Class II	1987-03-03
K863342	Softip Coronary Sinus Cardioplegia Catheter	Angiomedics, Inc.	DWF	Class II	1987-03-03
K861233	Dual Photon Bone Densitometer	Medical and Scientific Enterprises, Inc.	KGI	Class II	1987-03-03
K870579	Alpha-Dent Pit and Fissure Sealant	Wallace A. Erickson & Co.	EBC	Class II	1987-03-02
K870551	Intrauterine Insemination Catheter	Cook Ob/Gyn	HDR	Class II	1987-03-02
K870331	Imz Intramobile Cylinder Implant System Components	Interpore Intl.	EGG	Class I	1987-03-02
K864296	S.c.t. Multi Port, Injection Site	Salt Creek Medical Technologies	FPA	Class II	1987-03-02
K864158	Thermapad	Avail-Southwest Division	KME	Class I	1987-03-02
K863221	Omniplus Photosurgical Laser System for Ob-Gyn	Laserscope	HHR	Class II	1987-03-02
K870745	Stryker Model 977 Birthing Bed	Stryker Corp.	KNC	Class II	1987-02-27
K870266	Coltene Brilliant D.i. Direct Inlay System	Coltene, Inc.	EBF	Class II	1987-02-27
K870193	A+med Disposable Needle	Can-Am Surgical Corp.	FMI	Class II	1987-02-27
K870052	Infumix Mixing Container	Biodynamics Corp.	KPE	Class II	1987-02-27
K864997	Medtrac Vp Volumetric Infusion Pump	American Edwards Laboratories	FRN	Class II	1987-02-27
K864976	Soluset Calcium Demineralizing Solution	Endo Technic Corp.	EKS	Class I	1987-02-27