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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 777 of 3530

510(k) clearances, page 777 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K140899	Halo Medical Technologies Catalyst Midcrystl Halo Ultrasound System	Halo Medical Technologies	IYO	Class II	2014-05-05
K140887	Cobas Ct/ng V2.0 Test	Roche Molecular Systems Inc	LSL	Class II	2014-05-05
K140066	Infill Cervical	Pinnacle Spine Group, LLC	ODP	Class II	2014-05-05
K133204	Airview Mini Owie Dick Test Pack	Crosstex International, Inc.	JOJ	Class II	2014-05-05
K140856	Brachysource Seed Implants with Sourcecap Bioabsorbable Caps	C.R. Bard Inc	KXK	Class II	2014-05-02
K140638	Propeller System - Model 2	Reciprocal Labs Corporation	CAF	Class II	2014-05-02
K140407	Filmarray Gastrointestinal (Gi) Panel	BioFire Diagnostics, LLC	PCH	Class II	2014-05-02
K140272	Swift-Lock Anchor	Abbott Medical	GZB	Class II	2014-05-02
K134017	Gigalaser	Powermedic ApS	ILY	Class II	2014-05-02
K133934	Manuka Foam Hc, Manuka Foam Hc (with Acrylic Adhesive Border), Manuka Foam Hc (with Silicone Adhesive Border)	Links Medical Products, Inc.	FRO	Unclassified	2014-05-02
K133616	Matrixrib Fixation System	Synthes (USA) Products LLC	HRS	Class II	2014-05-02
K133530	Nuvasive EMG Endotracheal Tube	Nu Vasive, Incorporated	PDQ	Class II	2014-05-02
K133064	Mysign S Pulse Oximeter, Mysign Pc Software (Optional), Softtip Large R-3211-31, Finger Clip F-3211-31	Envitec-Wismar GmbH	DQA	Class II	2014-05-02
K133051	Pulmone Minibox Pft Tm	Pulmone Advanced Medical Devices, Ltd.	BZC	Class II	2014-05-02
K132476	Sharps Container	Grp & Associates	MMK	Class II	2014-05-02
K132167	I-Chroma Ifob with I-Chroma Reader	Boditech Med Inc.	OOX	Class II	2014-05-02
K132038	Accutorr 7 Vital Signs Monitor	Mindray North America	MWI	Class II	2014-05-02
K132004	Npwt Wound Dressing Kit- Medium, Npwt Wound Dressing Kit- Large	Creo Quality, LLC	OMP	Class II	2014-05-02
K140818	Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-05-01
K140216	Orthopedic Fixation Systems	Impact Medical, LLC	HRS	Class II	2014-05-01
K140185	Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console	Avinger, Inc.	PDU	Class II	2014-05-01
K133672	Reprocessed Harmonic Ace Shears without Adaptive Tissue Technology	Stryker Sustainability Solutions	NLQ	Unclassified	2014-05-01
K133514	Xcage Interbody Fusion System	Ouroboros Medical	MAX	Class II	2014-05-01
K133418	Integra Expandable Interverebral Body Fusion Device (Ibd) System	Seaspine, Inc.	MAX	Class II	2014-05-01
K133290	Collacare Dental	Innocoll Pharmaceuticals	KGN	Unclassified	2014-05-01
K132857	Respiratory Gas Humidifier	Pacific Medico Co., Ltd.	BTT	Class II	2014-05-01
K132637	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Zibo Intco Medical Products Company Limited	LYZ	Class I	2014-05-01
K132027	Oec 9800 Plus	GE Healthcare	OWB	Class II	2014-05-01
K131920	Stabilization Screw	In2Bones SAS	HWC	Class II	2014-05-01
K131866	Sustain	Hollender Sustainable Brands, LLC	HIS	Class II	2014-05-01
K122817	Silverlon Island Wound Dressing	Argentum Medical, LLC	FRO	Unclassified	2014-05-01
K140959	Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	IYN	Class II	2014-04-30
K133882	Carescape Central Station (Formally Known as Cic Pro)	GE Medical Systems Information Technologies, Inc.	DXJ	Class II	2014-04-30
K133600	Coeur, Inc. Frontload for Optivantage Power Injector	Coeur, Inc.	DXT	Class II	2014-04-30
K133590	Somatom Perspective	Siemens Medical Solutions USA, Inc.	JAK	Class II	2014-04-30
K133573	Fiagon Navigation System	Fiagon GmbH	PGW	Class II	2014-04-30
K133516	CO2 Monitoring Line, CO2 Monitoring Line with Filter	Flexicare Inc.	CCK	Class II	2014-04-30
K133149	Biopure Hx2 Reverse Osmosis Water Purification System	Evoqua Water Technologies LLC	FIP	Class II	2014-04-30
K132617	Medtronic Input Ps Introducer	Medtronic, Inc.	DYB	Class II	2014-04-30
K132178	Mostdi Dental Implant System	Mostdi Innovations Sdn Bhd	DZE	Class II	2014-04-30
K130065	Beautiful Image Facial Sculpting Device	Biosonic Technologies, LLC	NFO	Class II	2014-04-30
K140368	Family of Disposable Lenses	Sensor Medical Technology, LLC	HKS	Class I	2014-04-29
K140229	General Spinal System	Tianjin Walkman Biomaterial Co., Ltd.	MNI	Class II	2014-04-29
K140146	Comfortsoft Soft Denture Liner System	Whip-Mix Corp.	EBI	Class II	2014-04-29
K140125	New Stetic Dental Amalgam Alloy	New Stetic	OIV	Class II	2014-04-29
K133879	Fore-Sight Elite Absolute Tissue Oximeter	Cas Medical Systems, Inc.	MUD	Class II	2014-04-29
K133862	Accu-Chek Aviva Plus System	Roche Diagnostics GmbH	NBW	Class II	2014-04-29
K133387	Origio(r) Sequential Blast Tm; Origio(r) Sequential Blast Tm with Phenol Red	CooperSurgical, Inc.	MQL	Class II	2014-04-29
K132755	Neuromate Frameless Gen II	Renishaw Mayfield SARL	HAW	Class II	2014-04-29
K132570	Electric Handpiece System	Ttbio Corp.	EBW	Class I	2014-04-29