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 2026-11-05, 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 1373 of 3531

510(k) clearances, page 1373 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042008	Ultravisual	Emageon Uv, Inc.	LLZ	Class II	2004-09-03
K041853	Otogram	Tympany, Inc.	ETW	Class II	2004-09-03
K041844	All Safe Huber Safety Infusion Sets	Nexus Medical, LLC	FPA	Class II	2004-09-03
K041777	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	MNI	Class II	2004-09-03
K041627	Cystatin C Immunoparticles, Control Set, Calibrator	Dako A/S	NDY	Class II	2004-09-03
K041520	Mantra TENS Model Nt3	Mantra Intl. (Hk), Ltd.	GZJ	Class II	2004-09-03
K040493	Outologous Spinal Fixation System	Orthopedic Sciences, Inc	MNI	Class II	2004-09-03
K033026	Mallard Model 3000 Anesthesia Machine	Mallard Medical, Inc.	BSZ	Class II	2004-09-03
K042247	Synthetic (Blue) Vinyl Patient Examination Gloves - Powder Free	Shijiazhuang Hongxiang Plastics Products Co., Ltd.	LYZ	Class I	2004-09-02
K042192	Low Flow Osv II Hydrocephalus Valve	Integra Neurosciences Implants S.A.	JXG	Class II	2004-09-02
K042187	Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon 14,45 Tip Shape Micro Catheter,90	Medtronic, Inc.	KRA	Class II	2004-09-02
K042088	Samaritan Pad Pak Defibrillation Electrode, Model Spp-301	HeartSine Technologies Ltd	MKJ	Class III	2004-09-02
K041979	Mps Myocardial Protection System - Mps 2 Console, Model 5201260	Quest Medical, Inc	DTR	Class II	2004-09-02
K041647	Flexi-Stat Reusable Finger Clip Spo2 Sensors (Nellcor-Compatible),(bci-Compatible), (Datex-Compatible)	Elekon Industries U.S.A., Inc.	DQA	Class II	2004-09-02
K041639	Targetscn Transrectal Ultrasound System	Envisioneering, LLC	IYO	Class II	2004-09-02
K041638	Targetscan Biopsy Kit	Envisioneering, LLC	ITX	Class II	2004-09-02
K041405	Aspiration Pump, Model Imd-020	Industrial & Medical Design, Inc.	BTA	Class II	2004-09-02
K040903	Cadence, Models 2001 and 2002	Edan Instruments, Inc.	HGM	Class II	2004-09-02
K040858	Oralief Therapy for Sensitive Teeth	Novamin Technology, Inc.	LBH	Class II	2004-09-02
K040831	Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500	GE Healthcare	DPZ	Class II	2004-09-02
K040812	Detect Surgical Pacing and Mapping Tool	Medtronic, Inc.	LDF	Class II	2004-09-02
K033132	Stryker Switchpoint Infinity	STRYKER Communications, Inc.	GCJ	Class II	2004-09-02
K031788	Pathfinder	Massie Research Laboratories, Inc.	MXK	Class II	2004-09-02
K042229	Somatom Radiation Treatment Planning (Rtp) Package	Siemens Medical Solution, Inc. USA	JAK	Class II	2004-09-01
K042182	Y Clave Connector with Integrated Check Valve, Model XI-3432	Abbott Medical	FPA	Class II	2004-09-01
K042094	R&d Cbc-Xe Hematology Control	R & D Systems, Inc.	JPK	Class II	2004-09-01
K042010	Power Scooter, Model Tl-688	Teh Lin Prosthetic & Orthopaedic, Inc.	INI	Class II	2004-09-01
K042003	Infinity Trident Nmt Pod	Draeger Medical Systems, Inc.	KOI	Class II	2004-09-01
K041705	Resolution Thrombectomy System, Model Ev-2	Omnisonics Medical Technologies	QEY	Class II	2004-09-01
K041637	Targetscan Transrectal Ultrasound System	Envisioneering, LLC	ITX	Class II	2004-09-01
K041549	Zimmer Trabecular Metal Humeral Stem	Zimmer GmbH	KWT	Class II	2004-09-01
K041533	Synthes (USA) [Synthes} Peri-Prosthetic Screws	Synthes (USA) Products LLC	HWC	Class II	2004-09-01
K041502	Thrombelastograph (Teg) Platelet Mapping Assay	Haemoscope Corp.	JOZ	Class II	2004-09-01
K033491	Roche Diagnostics Cardiac D-Dimer Rapid Assay; Roche Diagnostics Cardiac D-Dimer Controls	Roche Diagnostics GmbH	DAP	Class II	2004-09-01
K031370	Shinmed Mode Sw-988 Untrasonic Nebulizer	Shining World Health Care Co., Ltd.	CAF	Class II	2004-09-01
K042273	Modification to Health Buddy with Device Connectivity	Health Hero Network, Inc.	DXN	Class II	2004-08-31
K042266	Acclaim	Air Techniques, Inc.	NRD	Class I	2004-08-31
K042265	Full Automatic (Nibp) Blood Pressure Monitor Model# Hl888	Health & Life Corporation	DXN	Class II	2004-08-31
K042246	Multi-Drip Infusion Catheter	Advanced Infusion, Inc.	MEB	Class II	2004-08-31
K042218	Accunet Embolic Protection System, Rx Accunet Embolic Protection System	Boston Scientific Corporation	NTE	Class II	2004-08-31
K042154	Ge Datex-Ohmeda Aisys Carestation	GE Healthcare	BSZ	Class II	2004-08-31
K042086	Fabius Gs Anesthesia System; Fabius Tiro Anesthesia System	Draeger, Inc.	BSZ	Class II	2004-08-31
K041901	Sd360 Digital Recorder/sd360 Holter Digital Recorder	North East Monitoring, Inc.	MWJ	Class II	2004-08-31
K041900	Hc604 CPAP Humidifier	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2004-08-31
K041778	Reizen Talking Blood Pressure Monitor, Model #Sf860t	Maxi-Aids, Inc.	DXN	Class II	2004-08-31
K041379	Pre-Powdered Vinyl Exam Gloves	Shijiazhuang Wally Plastics Co., Ltd.	LYZ	Class I	2004-08-31
K041089	Oss Bone Graft System and Oss Rapidset Bone Graft System	Biomet Manufacturing Corp	MQV	Class II	2004-08-31
K041034	Skin Level Gastrostomy Tube Kit (Ecsl)	Entracare Corp.	KNT	Class II	2004-08-31
K040562	Lifeclinic, Model 2400	Lifeclinic International, Inc.	DXN	Class II	2004-08-31
K040380	Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420	Dolphin Medical, Inc.	DQA	Class II	2004-08-31