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 1395 of 3531

510(k) clearances, page 1395 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040454	Biofill Bone Void Filler	Scient'X	MQV	Class II	2004-05-07
K040317	Ivc System	Mark H. Friedman	ILO	Class II	2004-05-07
K033789	Latex Powder-Free Examination Gloves with Coating	Cardinalhealth	LZC	Class I	2004-05-07
K033722	Apapore Bone Graft Substitute	Apatech Ltd.	MQV	Class II	2004-05-07
K033101	G-Pgd	Vitrolife Sweden AB	MQL	Class II	2004-05-07
K032927	Full Auto Arm Digital Blood Pressure Monitor	Sein Electronics Co., Ltd.	DXN	Class II	2004-05-07
K032894	Osteo Acl Screw Model;237020t, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,	Linvatec Biomaterials, Ltd.	HWC	Class II	2004-05-07
K032877	G-Oocyte	Vitrolife Sweden AB	MQL	Class II	2004-05-07
K032400	Lafaci	Vision Pro, LLC	FYD	Class II	2004-05-07
K032155	G-Thawkit Blast	Vitrolife Inc.	MQL	Class II	2004-05-07
K032154	G-Freezekit Blast	Vitrolife Inc.	MQL	Class II	2004-05-07
K030396	Omni~neb; Omni~max	B & B Medical Technologies, Inc.	CAF	Class II	2004-05-07
K041099	Modification to Spsmedical Sporview Bacterial Spore Strip	Spsmedical Supply Corp.	FRC	Class II	2004-05-06
K041093	Numed Mullins X Pta Catheter	Numed Inc	DQY	Class II	2004-05-06
K041061	D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters	Dideco S.p.A.	DTM	Class II	2004-05-06
K040893	Easy Core Biopsy System	Boston Scientific Corporation	FCG	Class II	2004-05-06
K040801	Intra-Aortic Balloon (Iab)	Arrow Intl., Inc.	DSP	Class II	2004-05-06
K040397	Modification to Cyclone Anterior Cervical Plate System	Encore Medical, LP	KWQ	Class II	2004-05-06
K040225	Oti Alumina Ceramic Femoral Head System	Osteoimplant Technology, Inc.	KWZ	Class II	2004-05-06
K033307	Nvision Data Management Software	Nonin Medical, Inc	DQA	Class II	2004-05-06
K033273	Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads	Depuy Orthopaedics Inc.	LPH	Class II	2004-05-06
K041010	Remstar Auto with C-Flex CPAP System	Respironics, Inc.	BZD	Class II	2004-05-05
K040983	Lorenz Self-Drilling Imf Screw	Biomet Microfixation	DZE	Class II	2004-05-05
K040948	Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/n 400170	Intuitive Surgical, Inc.	NAY	Class II	2004-05-05
K040641	Ultracinch Ablation Device, Ultracinch Accessory Pack, Models Uc-8, Uc-9, Uc-10, Uc-11, Uc-12, Uc-13, Uc-14, Uc-Acc-1	Epicor Medical, Inc.	NTB	Class II	2004-05-05
K040629	Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine	Accu-Stat Diagnostics, Inc.	LDJ	Class II	2004-05-05
K040536	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2004-05-05
K040506	Flexifil Series Hc431 Full Face Mask, Model Hc431a	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2004-05-05
K040410	Greenlight 300	A C Cossor & Son (Surgical) Limited	DXN	Class II	2004-05-05
K040294	Laserpro Diode Laser Systems, Models 810, 940 & 980	Photo Medex, Inc.	GEX	Class II	2004-05-05
K040268	Depuy Preservation Unicondylar Tibia	Depuy Orthopaedics Inc.	HRY	Class II	2004-05-05
K040267	Triathlon Cruciate Retaining (Cr) Total Knee	Howmedica Osteonics Corp	JWH	Class II	2004-05-05
K040196	Kendall Epump Enteral Feeding Pump and Enteral Feeding Sets	Tyco Healthcare/Kendall	LZH	Class II	2004-05-05
K040069	Dymedix Reusable Airflow/snore Sensor	Dymedix, Inc.	MNR	Class II	2004-05-05
K034033	Rescan	ResMed Corp	BZD	Class II	2004-05-05
K033833	Eflow Electronic Inhaler/nebulizer	Pari Innovative Manufacturers, Inc.	CAF	Class II	2004-05-05
K033670	Gore Tri-Lobe Balloon Catheter	W. L. Gore & Associates, Inc.	DQY	Class II	2004-05-05
K033550	Dxl Calscan	Demetech Corp.	KGI	Class II	2004-05-05
K033018	Stimulong Plus Catheter Set Model, Various	Pajunk GmbH Medizintechnologie	CAZ	Class II	2004-05-05
K030810	Coolan 300	Coolanalgesia, Ltd.	GEX	Class II	2004-05-05
K040877	Artoscan C	Esaote S.p.A.	LNH	Class II	2004-05-04
K040404	Heartstart Mrx, Model M3535a	Philips North America LLC	MKJ	Class III	2004-05-04
K040376	Sectra Ids5 Radiology Workstation; Sectra Mpr Package; Sectra 3D Package	Sectra-Imtec AB	LLZ	Class II	2004-05-04
K040146	Interlab Acid Hemoglobin Electrophoresis Test System	Interlab S.r.l.	GKA	Class II	2004-05-04
K033216	Bz-576 Non-Invasive Automatic Blood Pressure Monitor	The Buzz Group, LLC	DXN	Class II	2004-05-04
K033189	King Lts Reusable Oropharyngeal Airway with Drain/suction Channel, Models Klt 303, Klt 304 and Klt 305	King Systems Corporation.	CAE	Class I	2004-05-04
K041025	Buzzaround, Vehicle, Motorized 3-Wheeled	Golden Technologies, Inc	INI	Class II	2004-05-03
K040936	Petit Silma Elastic Bandage with Germanium/titanium Oxide	Leda Co., Ltd.	FQM	Class I	2004-05-03
K040856	Rapid Aid Instant Disposable Infant Heel Warmer	Rapid Aid Corp.	MPO	Class I	2004-05-03
K040669	Ceraform Bone Void Filler	Teknimed SAS	MQV	Class II	2004-05-03