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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2478 of 3531

510(k) clearances, page 2478 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K901287	Intherm Temporary Occlusion Catheter	Interventional Therapeutics Corp.	DYG	Class II	1991-02-20
K900181	Micro-Vent Endosseous Implant Abutments	Core-Vent Corp.	DZE	Class II	1991-02-20
K900179	Screw-Vent Endosseous Implant Abutments	Core-Vent Corp.	DZE	Class II	1991-02-20
K910542	Digiflex, Latex Patient Examination Gloves	21st Century Group	LYY	Class I	1991-02-19
K910512	Accuflate	Instrumed, Inc.	KCY	Class I	1991-02-19
K910495	Qualtex Surgical Drape	DeRoyal Industries, Inc.	KKX	Class II	1991-02-19
K910458	Zara Soft Tip Chin Implant	Byron Medical	FWP	Class II	1991-02-19
K910457	Zara Extended Chin Implant	Byron Medical	FWP	Class II	1991-02-19
K910456	Zara Chin Implant	Byron Medical	FWP	Class II	1991-02-19
K910357	Som 6V	JEDMED Instrument Company	FSO	Class I	1991-02-19
K905835	Mrp-7000: Supplemental r/f Coils	Summit World Trade Corp.	LNH	Class II	1991-02-19
K905834	Mrp-7000(1) : 2-D Inflow Mr Angiography	Summit World Trade Corp.	LNH	Class II	1991-02-19
K905724	Ionobond	Micro-Vac, Inc.	EJK	Class II	1991-02-19
K905718	Romflex	Paraflex Corp.	BXB	Class I	1991-02-19
K905701	Richard-Allan Sheet Clip	Richard-Allan Medical	KKX	Class II	1991-02-19
K905682	Richard-Allan Clamp Covers	Richard-Allan Medical	FSM	Class I	1991-02-19
K905641	Fst Cath-Ud Catheter	Fiberoptic Sensor Technlogies, Inc.	FEN	Class II	1991-02-19
K905581	Silicone Coated Guidewires	Lake Region Mfg., Inc.	DQX	Class II	1991-02-19
K905549	The Dart	Dexide, Inc.	HIF	Class II	1991-02-19
K905314	Algoderm Alginate Wound Dressing	Les Laboratorires Brothier, S.A.	FRO	Unclassified	1991-02-19
K905295	Catalog Number 2609 Leg Plate	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1991-02-19
K905279	Condom (Rubber) Contraceptive	Aladan Corp.	HIS	Class II	1991-02-19
K905249	New Usci 7F Ptca Guiding Catheter	C.R. Bard Inc	DQY	Class II	1991-02-19
K905212	Immittance Meter, Model Ae-105D/s	American Electromedics Corp.	ETY	Class II	1991-02-19
K904700	Endocoagulator Krs568(tm) Laser	Hgm Medical Laser Systems, Inc.	GEX	Class II	1991-02-19
K904691	Air-Shields Vickers Telescan Telecom Display Syst	Air-Shields Vickers, Inc.	HFM	Class II	1991-02-19
K904266	Autoderm Scanner Control Console	Charles I. Rose & Co., Inc.	GEX	Class II	1991-02-19
K904240	Single Use Laparscopic Electrode	Aspen Labs	HFG	Class II	1991-02-19
K904169	Vpw 2903 a-1 -208V, B2-440V,c3-240V X-Ray Supply	Varian Canada, Inc.	IZO	Class I	1991-02-19
K904000	Trojan(r) Extra Str Latex Condom W/sperm Sili Lubr	Armkel, LLC	HIS	Class II	1991-02-19
K903771	Hp Model M1008b, Noninvasive Blood Pressure Module	Hewlett-Packard Co.	DXN	Class II	1991-02-19
K903321	Sandbox I, Sandbox II, Sandbox Jr.	Sandbox Ent.	IRT	Class II	1991-02-19
K903131	Lasermatic Supercombo(tm) Surgical Laser System	Lasermatic, Inc.	GEX	Class II	1991-02-19
K900723	Itc Bunji Coil	Interventional Therapeutics Corp.	HCG	Class II	1991-02-19
K900180	Core-Vent Endosseous Implant Abutments	Core-Vent Corp.	DZE	Class II	1991-02-19
K905854	Condoms	Barnetts, Inc.	HIS	Class II	1991-02-15
K905315	Ultracision Harmonic Scalpel	Ultracision, Inc.	GEI	Class II	1991-02-15
K905270	Ochsner 50 Vascular Prosthesis	Intervascular, Inc.	DSY	Class II	1991-02-15
K905188	Perio Pik	Teledyne Water Pik	EFS	Class I	1991-02-15
K905186	Geri Total Hip System	Smith & Nephew Richards, Inc.	LWJ	Class II	1991-02-15
K905184	Isola(tm) Spine System Top Entry Hook	Acromed Corp.	KWP	Class II	1991-02-15
K904404	Multi-Lumen Central Venous Catheter Set	Arrow Intl., Inc.	DQY	Class II	1991-02-15
K902256	Irrigation Catheter 4, 6 and 10 French	Applied Vascular Devices, Inc.	DQY	Class II	1991-02-15
K910455	Ims Disposable Holder with Needle Retractor	Ziehm International, Inc.	FMI	Class II	1991-02-14
K910265	Traveler, Motorized Three-Wheeled Vehicle	Pillar Technology, Inc.	INI	Class II	1991-02-14
K910118	Data Recorder	Healthdyne, Inc.	FLL	Class II	1991-02-14
K910043	Tenone(tm) Methamphetamine	Siemens Healthcare Diagnostics Inc.	LAF	Class II	1991-02-14
K905652	Myocardial Temperature Monitoring Probes, Cj-1000	Daily Medical Products, Inc.	FLL	Class II	1991-02-14
K905525	Cybex 6000	Cybex	IKK	Class II	1991-02-14
K905237	Eye See Instrument	King Tool, Inc.	HPN	Class I	1991-02-14