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 982 of 3531

510(k) clearances, page 982 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103271	Msc Lipid Control	Maine Standards Co.	JJY	Class I	2011-01-25
K103166	Cheetah Reliant	Cheetah Medical, Inc.	DSB	Class II	2011-01-25
K102853	Flamenco Spinal Fixation System	Ulrich GmbH & Co. KG	MNH	Class II	2011-01-25
K102713	Tiger Flat Surgical Mask	Tiger Medical Products, Ltd.	FXX	Class II	2011-01-25
K102561	Orthodontic Ceramic Bracket	Ht Co., Ltd.	NJM	Class II	2011-01-25
K101741	Diatron Pictus 400	Diatron Group	CGA	Class II	2011-01-25
K101225	Promimic Dental Implant, 3.75 Mm, Length 8.5 Mm Model 03-1001, Promimic Dental Implant, 3.75 Mm, Length 10 Mm Model 03-1	Promimic AB	DZE	Class II	2011-01-25
K101171	Orthovita Peek Spacer	DSM Biomedical, Inc.	ODP	Class II	2011-01-25
K100875	Cerox, Model 321Of	Or-Nim Medical, Ltd.	MUD	Class II	2011-01-25
K100794	Fluorcanasite Dental Ceramic	Dr Sarah Pollington	EIH	Class II	2011-01-25
K093989	Oral Fluid Phencyclidine	Roche Diagnostics GmbH	LCM	Unclassified	2011-01-25
K090145	Surecall EMG Labor Monitor	Reproductive Research Technologies, LP	OSP	Class II	2011-01-25
K103332	Aptus Ulna Plates	Medartis AG	HRS	Class II	2011-01-24
K103231	Kyphon Inflation Syringe	Medtronic Spine, LLC	HRX	Class II	2011-01-24
K103157	Disposable Prophy Angle; Disposable Prophy Angle	Angstrom Mfg., Inc.	EGS	Class I	2011-01-24
K102670	Total Shoulder System	SHOULDER INNOVATIONS, Inc	KWS	Class II	2011-01-24
K102336	Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps; Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps with Ne	Boston Scientific Corporation	BWH	Class II	2011-01-24
K102218	Compact Piezo P2k, Powercare	Mectron S.p.A.	ELC	Class II	2011-01-24
K102123	Vizion Dr	Viztek, LLC	KPR	Class II	2011-01-24
K101604	Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V	Vascular Solutions LLC	DYB	Class II	2011-01-24
K100823	Wound Pro Apex	Accuro Medical Products, LLC	OMP	Class II	2011-01-24
K100591	Sorbact	Abigo Medical AB	FRO	Unclassified	2011-01-24
K110131	Lava Ultimate Cad/cam Restorative for Cerec / E4d, Lava Ultimate Implant Crown Restorative	3M ESPE Dental Products	EBF	Class II	2011-01-21
K103755	Taperloc Complete, Size 5 and 6	Biomet Manufacturing Corp	KWA	Class III	2011-01-21
K103746	Carto 3 Ep Navigation System, Version 2.0 (W/standard Location Pad),carto3 Epnavigation System,version 2.0 W/rmt Pad)	Biosense Webster Inc	DQK	Class II	2011-01-21
K103580	Grandio So Flow	Voco GmbH	EBF	Class II	2011-01-21
K103529	Liaison Xl Analyzer Model 10050	Diasorin Inc.	LOL	Class II	2011-01-21
K103243	2.4Mm Va-Lcp Intercarpal Fusion System	Synthes (USA) Products LLC	HRS	Class II	2011-01-21
K103141	Low Adherent Afm Ag Dressings	Milliken Healthcare Products, LLC	FRO	Unclassified	2011-01-21
K102870	Exactech Proliant Polyaxial Pedicle Screw System	Exactech, Inc.	MNH	Class II	2011-01-21
K102775	Hamilton-C2	Hamilton Medical AG	CBK	Class II	2011-01-21
K102227	Infa Warmer I	Atom Medical Corporation	FMT	Class II	2011-01-21
K102154	Tyro-97 (Hofocon a), Onsi 56 (Hofocon), Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens	The Lagado Corp.	HQD	Class II	2011-01-21
K101894	Healthlight Microcontroller, Minipro, Proneurolight, and Pro Unit	Bioremedi Therapeutic Systems, Inc.	ILY	Class II	2011-01-21
K101354	Fetch 2 Aspiration Catheter Model 109400-001	Medrad Interventional/Possis	QEZ	Class II	2011-01-21
K101147	Modified Alma Lasers Family of Accent Radiofrequency (RF) System	Alma Lasers Ltd.	NUV	Class II	2011-01-21
K100957	Deployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen Ceoncentration	Pacific Consolidated Industries LLC	CAW	Class II	2011-01-21
K100625	Realeye Model Vcps	Navotek Medical, Ltd.	IYE	Class II	2011-01-21
K093101	Mago 4S	Diamedix Corp.	LFX	Class II	2011-01-21
K090754	Lipocontrol	Osyris Medical	ORK	Class II	2011-01-21
K090626	Endoserter	Ocular Systems, Inc.	OTZ	Class I	2011-01-21
K110020	Terason T3200 Ultrasound System	Teratech Corp.	ITX	Class II	2011-01-20
K103762	Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X Rp 150 and Control Panel with Connecting Cables); S5/c5 Mast Rolle	LivaNova Deutschland GmbH	DTQ	Class II	2011-01-20
K103715	Compass Vascular Access / Access Port / Lumbar Puncture / Intracranial Pressure	Mirador Biomedical, Inc.	DRS	Class II	2011-01-20
K103539	Quanta System Duolite	Quanta System Inc.	GEX	Class II	2011-01-20
K103468	Stockert Centrifugal Pump (Scp Plus) (Complete) or (for S5/c5 Systems)	LivaNova Deutschland GmbH	DWA	Class II	2011-01-20
K103351	Dmc Composite 2	Sybron Dental Specialties, Inc.	EBF	Class II	2011-01-20
K103017	Mederi Therapeutics RF Generator Control Module	Curon Medical, Inc.	GEI	Class II	2011-01-20
K102940	Vascopress Sequential Dvt Pump	Compression Therapy Concepts, Inc.	JOW	Class II	2011-01-20
K102914	Tq Hba1c Gen3	Roche	LCP	Class II	2011-01-20