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 960 of 3531

510(k) clearances, page 960 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103703	Reguis Sigma	Konica Minolta Medical & Graphic, Inc.	MQB	Class II	2011-06-02
K103578	Philips Nm3 Respiratory Monitor with Ventassist	Respironics Novametrix, LLC.	BZK	Class II	2011-06-02
K103548	Advia Centaur Calibarator 80 Model 10492491	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2011-06-02
K103205	Bridgepoint Spinous Process Camp- Posterior Fixation System	Alphatec Spine, Inc.	KWP	Class II	2011-06-02
K102811	Aos Orion Ir-192 Source Cable	Alpha Omega Services Inc	KXK	Class II	2011-06-02
K102567	Watch-Pat 200S-3 (Wp200s-3)	Itamar Medical	MNR	Class II	2011-06-02
K102490	Igx Plex Celiac Qualitative Assay	Sqi Diagnostics Systems	MVM	Class II	2011-06-02
K102479	Alara T210 Computed Radiography System	Alara, Inc.	MQB	Class II	2011-06-02
K102461	Fractora	Invasix Inc.	GEI	Class II	2011-06-02
K100943	Invader Factor II	Hologic, Inc.	NPR	Class II	2011-06-02
K111229	Jetstream G3 (R) Sf 1.6 System	Pathway Medical Technologies, Inc.	MCW	Class II	2011-06-01
K110516	Connex Vital Signs Monitor 6000 Series	Welch Allyn Inc	MWI	Class II	2011-06-01
K110398	Respironics Disposable Heated Wire Circuits	Respironics, Inc.	BZE	Class II	2011-06-01
K103738	H-Wave	Electronic Waveform Laboratory, Inc.	IPF	Class II	2011-06-01
K103423	Mis Anterior Cervical Plating System	Life Spine	KWQ	Class II	2011-06-01
K103023	Unit, Phacofragmentation	Advanced Medical Optics, Inc.	HQC	Class II	2011-06-01
K100980	Invader Factor V	Hologic, Inc.	NPQ	Class II	2011-06-01
K111295	.014 Monorail and Otw Pta Balloon Dilatation Catheters	Boston Scientific Corporation	LIT	Class II	2011-05-31
K110957	M4 Monitor	Spectrum Medical Inc	DRY	Class II	2011-05-31
K110268	Forcetriad Electrosurgical Generator	Covidien Lp, Formerly Know AS Valleylab, A Divison	GEI	Class II	2011-05-31
K111330	Air Techniques High Frequency Intra-Oral X-Ray	Skanray Technologies Limited	EHD	Class II	2011-05-27
K111283	Gmk Revision Hybrid Liners	Medacta International SA	JWH	Class II	2011-05-27
K111251	4Ch Flex Speeder	Toshiba Medical Systems Coporation, Japan	MOS	Class II	2011-05-27
K111098	Innovaxion Fp, Innovaxion Fp 1600 Plus, Magellan	Imaging Dynamics Company, Ltd.	MQB	Class II	2011-05-27
K110785	Kalare Diagnostic X-Ray Table System	Toshiba Medical Systems Coporation, Japan	JAA	Class II	2011-05-27
K110781	5.5 / 6.5Mm Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction Tool, 5.5 / 6.5Mm Punch Tap	ArthroCare Corporation	MBI	Class II	2011-05-27
K110642	Siljetr System	Danville Materials, Inc.	EBF	Class II	2011-05-27
K110641	Fujirebio Diagnostics Vitamin D Control	Fujirebio Diagnostics, Inc.	JJX	Class I	2011-05-27
K110589	Cimara	Voco GmbH	EBF	Class II	2011-05-27
K110447	Echoinsight	Ultrasound Medical Devices, Inc.	LLZ	Class II	2011-05-27
K110256	The Ic-Pro System	Paieon, Inc.	IZI	Class II	2011-05-27
K110233	Hairmax Lasercomb	Lexington International, LLC	OAP	Class II	2011-05-27
K110226	Interfuse T Invertebral Body Fusion Device	Vertebral Technologies, Inc.	MAX	Class II	2011-05-27
K110214	Directvision Catheter, Uncoated	Percuvision, LLC	EZL	Class II	2011-05-27
K110097	Acclarent Cyclops Multi-Angle Endoscope	Acclarent Inc	EOB	Class II	2011-05-27
K103775	Peak Suction Coagulator	Peak Surgical, Inc.	GEI	Class II	2011-05-27
K102935	Infrared Ear Thermometer, Models Tm819, Tm820, Tm817, Tm810a, Tm810b, Tm818 and Tm818a	Kingtech Enterprise, Ltd.	FLL	Class II	2011-05-27
K102049	Clever Choice Voice+ Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2011-05-27
K101952	Konix Ultrasound Gel	Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa	ITX	Class II	2011-05-27
K101681	Transtek Blood Pressure Monitor Model Tmb-986, Tmb-987, Tmb-995	Zhongshan Transtek Electronics Co., Ltd	DXN	Class II	2011-05-27
K101251	Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap Allergen D203, Allergen	Phadia AB	DHB	Class II	2011-05-27
K100895	Palm-Pro 0.30Mm Powder Free Latex Examinaion Gloves (6Pf2g30)	Dipped Products Limited	LYY	Class I	2011-05-27
K092338	Medax Unipersonale Srl	Medax Unipersonale SRL	KNW	Class II	2011-05-27
K111042	Atricure Cryo Module	AtriCure, Inc.	GEH	Class II	2011-05-26
K110718	Cell-Chex with Cppd Crystals	Streck LLC	GLQ	Class II	2011-05-26
K110422	Surgical Stimulators	Technomed Europe	ETN	Class II	2011-05-26
K110090	Afx Introducer System	Endologix LLC	DYB	Class II	2011-05-26
K103653	E3 Torque Control Motor	Dentsply International, Inc.	EBW	Class I	2011-05-26
K101128	Biofriend Biomask Surgical Facemask, Models Universal Bf-200-2001 and Premium Bf-200-3013	Filligent Limited	OUK	Class II	2011-05-26
K100831	Cyfra 21-1 Eia Model 211-10	Fujirebio Diagnostics, Inc.	OVK	Class II	2011-05-26