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 1404 of 3531

510(k) clearances, page 1404 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K033954	Shape Locking Endoscopic Overtube	Usgi Medical	FED	Class II	2004-03-19
K033594	Optimum Gp (Oxygen Permeable) Daily Wear Contact Lenses	Contamac Ltd.	HQD	Class II	2004-03-19
K033389	Powerpicc Catheters, Models 3175155, 3175135	C.R. Bard Inc	LJS	Class II	2004-03-19
K032864	Ceralas D 810 Diode Laser System, Model D15	Biolitec, Inc.	GEX	Class II	2004-03-19
K032863	Ceralas D 980 Diode Laser System, Models D15, D25, D50	Biolitec, Inc.	GEX	Class II	2004-03-19
K032086	Kryo Art Controlled Rate Freezer	PLANER Limited	MQG	Class II	2004-03-19
K031084	Solar Gi System	Medical Measurement Systems B.V.	FFX	Class II	2004-03-19
K023060	Acculaser Pro4	Acculaser, Inc.	NHN	Class II	2004-03-19
K040631	Vitalab Direct Bilirubin Reagent	Clinical Data, Inc.	CIG	Class II	2004-03-18
K040595	Alice 5	Respironics, Inc.	OLZ	Class II	2004-03-18
K040539	Elliptic Matrix	Straumann USA, LLC	NHA	Class II	2004-03-18
K040481	Safe-Cross Deflecting Catheter, Model C118nd1	Intra Luminal Therapeutics, Inc.	DQY	Class II	2004-03-18
K040421	Duceragold Porcelains	Dentsply Intl.	EIH	Class II	2004-03-18
K040420	Duceram Plus Ceramic System	Dentsply Intl.	EIH	Class II	2004-03-18
K040073	Sysmex Automated Hematology Analyzer, Xe-2100 Series (Xe-2100, Xe-2100L)	Sysmex America, Inc.	GKZ	Class II	2004-03-18
K040036	Inviro Snap Safety Insulin Syringe, 1 Cc, Model 102905	Inviro Medical	MEG	Class II	2004-03-18
K033415	Idi-Mrsa	Infectio Diagnostic (I.D.I.), Inc.	NQX	Class II	2004-03-18
K033297	Zap Hcg Test, Model 8001	Zbx Corporation	JHI	Class II	2004-03-18
K033208	Ivy Devices Inc. Iv/medical Line Stabilizer	Ivy Devices, Inc.	FPA	Class II	2004-03-18
K033200	Ariol	Applied Imaging Corp.	NQN	Class II	2004-03-18
K032860	Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga)	Immco Diagnostics, Inc.	NBT	Class II	2004-03-18
K032850	Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg)	Immco Diagnostics, Inc.	NBT	Class II	2004-03-18
K032509	Mark 5 Nuvo (M5c5)	Nidek Medical Products Inc	CAW	Class II	2004-03-18
K040558	Modification to: Collagen Topical Wound Dressing	Collagen Matrix, Inc	KGN	Unclassified	2004-03-17
K040538	Bioarc Sp Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996	American Medical Systems, Inc.	OTN	Class II	2004-03-17
K040510	Vascular Solutions D-Stat Dry 3X3 Hemostatic Pad	Vascular Solutions LLC	QSX	Unclassified	2004-03-17
K040408	Polymer Coated, Powder-Free Latex Examination Gloves with Protein Labeling (Less Than 50 Ug/g per Glove)	Shun Thai Rubber Gloves Industry Public Co., Ltd.	LYY	Class I	2004-03-17
K040121	Dermawave 5000 Combi Max System	Dermawave, LLC	IMG	Class II	2004-03-17
K040119	Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration	SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)	FTM	Class II	2004-03-17
K040039	Nio 2Mp Medical Grayscale Display System	Barco N.V.	LLZ	Class II	2004-03-17
K033955	Rtist	Mirada Solutions, Ltd.	LLZ	Class II	2004-03-17
K033923	Th0r Ddii Ir Lamp System	Thor Intl.	ILY	Class II	2004-03-17
K033920	Caas II Rva	PIE Medical Imaging B.V.	LLZ	Class II	2004-03-17
K033729	Collagen Dental Wound Dressings	Collagen Matrix, Inc	LYC	Class II	2004-03-17
K033291	Topseal Hemostatic Dressing, Model 11150	Radi Medical Systems AB	QSY	Unclassified	2004-03-17
K032896	Anson Refix Vascular and Tissue Clip, Models Gf-04-01 and Gf-04-02	Anson Medical, Ltd.	FZP	Class II	2004-03-17
K032671	Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/n 0386-0010-07	Gebauer Co	MLY	Unclassified	2004-03-17
K032451	Bird Tbird Vela Ventilator	Bird Products Corp.	CBK	Class II	2004-03-17
K031142	Disposable Powdered Vinyl Synthetic Exam Gloves, White Color	Shanghai Palomar Mountain Industries, Inc.	LYZ	Class I	2004-03-17
K030624	Modification to Fabius Gs Anesthesia System	Draeger, Inc.	BSZ	Class II	2004-03-17
K040550	Lifestent Sds and Xl Sds Biliary Endoprosthesis	Orbusneich Medical, Inc.	FGE	Class II	2004-03-16
K040505	Zilver 635 Biliary Stent	Cook Inc.	FGE	Class II	2004-03-16
K040503	Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural Colour	WRP Asia Pacific Sdn Bhd	KGO	Class I	2004-03-16
K040492	Vaxcel Plus Chronic Dialysis Catheter Tunneler	Boston Scientific Corporation	MSD	Class II	2004-03-16
K040162	Correstore Patch System	Somanetics Corp.	DXZ	Class II	2004-03-16
K034032	Plv Continuum Ventilator, Model P2000	Respironics, Inc.	NOU	Class II	2004-03-16
K034012	Smith & Nephew RF Denervation Probes & RF Cannulae	Smith & Nephew, Inc.	GXI	Class II	2004-03-16
K033933	Powerlite 600 Ex System	Preswede AB	GEX	Class II	2004-03-16
K040551	Coltolux LED Curing Light	Coltene /Whaledent AG	EBZ	Class II	2004-03-15
K040472	Force Fiber Blue Co-Braided Polyethylene Nonabsorbable Surgical Suture	Teleflex Medical	GAT	Class II	2004-03-15