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 1019 of 3531

510(k) clearances, page 1019 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100429	Urgocell Ag, Antimicrobial Wound Dressing with Silver	Laboratoires Urgo	FRO	Unclassified	2010-06-11
K100129	Ambu Blue Sensor Neo, Ambu Blue Sensor Neo X	Ambu A/S	DRX	Class II	2010-06-11
K100101	Gsp Neonatalgalt Kit, Model 3303-001U	Revvity Health Sciences, Inc.	KQP	Class II	2010-06-11
K094022	The Water Lily	Clearwater Products, LLC	KPL	Class II	2010-06-11
K093340	Pasr/quietnite	Exact Supplies, Ltd.	LRK	Class II	2010-06-11
K093118	Brainlab Knee Arthroscopy	Brainlab, Inc.	OLO	Class II	2010-06-11
K092987	Inratio/inratio2 Test Strips	Biosite Incorporated	GJS	Class II	2010-06-11
K101262	Flexi-Lite	Pressure-Tech, Inc.	CBF	Class II	2010-06-10
K101044	Retrieve Implant Cement	Parkell, Inc.	EMA	Class II	2010-06-10
K100137	Sidekick Circular Fixator System: Struts and Hinges	Wrightmedicaltechnologyinc	KTT	Class II	2010-06-10
K093931	Blood Pressure Meter, Model Ch-4532	Citizen Systems Japan Co., Ltd.	DXN	Class II	2010-06-10
K093679	Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model Various Laa0	AtriCure, Inc.	FZP	Class II	2010-06-10
K093442	Guided Growth System	Orthofix SRL	OBT	Class II	2010-06-10
K092731	Vibro-Trac	Pneumex, Inc.	JFB	Class II	2010-06-10
K100772	Mirage Micro Model 16333 (S), 16334 (M&l), 16335 (Lw & Xl)	ResMed Corp	BZD	Class II	2010-06-09
K100754	Graft Delivery System Model Sa-6115	Micromedics, Inc.	FMF	Class II	2010-06-09
K100711	Suction Irrigation Electrodes and Adapters	Encision, Inc.	GEI	Class II	2010-06-09
K100623	Aesculap Implant Systems S4 Spinal System	Aesculap Inc	NKB	Class II	2010-06-09
K100398	Smartlink Gold Blood Glucose Monitoring System	Standard Diagnostics, Inc.	NBW	Class II	2010-06-09
K093819	Arkray Diabetes Data Management Software (Smbg Viewer)	Arkray Factory USA, Inc.	NBW	Class II	2010-06-09
K093297	Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube	Epocal Inc	KHP	Class I	2010-06-09
K101445	Vital Signs Monitor-Vsm 6000 Series	Welch Allyn Inc	MWI	Class II	2010-06-08
K101008	Digital Color Doppler Ultrasound Imaging System, Convex Array Transducer, Linear Array	Shantou Institute of Ultrasonic Instruments (Siui	ITX	Class II	2010-06-08
K101002	A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200	Healthstats International Pte., Ltd.	DXN	Class II	2010-06-08
K100509	Thl1 Laser	Erchonia Corporation	NHN	Class II	2010-06-08
K100217	Lucon M-Series Patient Monitor, Models M20 and M30	Mediana Co., Ltd.	MHX	Class II	2010-06-08
K093729	Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4Mm, Sterile, Guard Iva Antimicrobial Haemostatic IV Dressing, 1 I	Hemcon Medical Technologies Europe, Ltd.	QSY	Unclassified	2010-06-08
K093193	La Glove Brand Colored Latex Examination Gloves, Powder Free, Non Sterile (Pink/ Green/ Violet)	La Glove (M) Sdn. Bhd.	LYY	Class I	2010-06-08
K092967	Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe	Pathwork Diagnostics, Inc.	OIW	Class II	2010-06-08
K101013	Modification to Scintron IV	Miegmbh	KPS	Class II	2010-06-07
K100885	Fetal Monitor Model: Bt-200T	Bistos co., Ltd.	HGM	Class II	2010-06-07
K100807	Miniarc Precise Single-Incision Sling System Model: 720181, 720191	American Medical Systems, Inc.	PAH	Class II	2010-06-07
K092983	Panpac Hsg Catheter Set	Panpac Medical Corporation	LKF	Class II	2010-06-07
K091845	Cardiolipin Autoantibody Immunological Test System	Phadia AB	MID	Class II	2010-06-07
K101277	Orion II (Heavy Duty 350 Lbs and 500 Lbs)	Future Mobility Healthcare Inc.	IOR	Class I	2010-06-04
K100708	Pioneer Anterior Cervical Plate Model 24-Series	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWQ	Class II	2010-06-04
K100605	Mis System	Spine Wave Inc	MNH	Class II	2010-06-04
K100545	Sleepright	Power Products, Inc.-Splintek	OBR	Unclassified	2010-06-04
K093975	Simpler Toadstool Abutment, Model S19000-S19009	Pan Global Implant	NHA	Class II	2010-06-04
K093853	Single-Patient Use Disposable Sensor Series	Nonin Medical, Inc	DQA	Class II	2010-06-04
K093537	Hanarostent Esophagus (Ccc)	M.I.Tech Co Ltd	ESW	Class II	2010-06-04
K101297	Virtue Ventral Urethral Elevation Sling System Model 50020	MEDLINE INDUSTRIES, LP - Northfield	OTM	Class II	2010-06-03
K101030	Modification to Hbs Headless Bone Screw	Biopro, Inc.	HWC	Class II	2010-06-03
K100833	Syle Smartip	Osspray, Ltd.	EFB	Class I	2010-06-03
K100812	Ulticare Disposable Pen Needles	Ultimed, Inc.	FMI	Class II	2010-06-03
K100775	Bd Intima II Closed IV Catheter	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2010-06-03
K100546	Parker Flex- Tip Oral/nasa Intubation Tube	Parkermedicalinc	BTR	Class II	2010-06-03
K094056	Hotdog Multi Function Controller	Augustine Biomedical & Design, LLC	DWJ	Class II	2010-06-03
K093630	Biodenta Dental Implant System	Biodenta Swiss AG	DZE	Class II	2010-06-03
K093211	Carecenter Md	ZOLL Medical Corporation	DPS	Class II	2010-06-03