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 2036 of 3531

510(k) clearances, page 2036 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942243	Imex 8000 Personal Cascular Lab	Imex Medical Systems, Inc.	IYO	Class II	1995-11-03
K935916	Lip Grip Cap Holder	Daryl C. Fallas	FMI	Class II	1995-11-03
K954871	Laparoscopic Instrument Grounding System	Conmedcorp	GEI	Class II	1995-11-02
K954762	Nexus	Sybron Dental Specialties, Inc.	EMA	Class II	1995-11-02
K954761	Finesse Low-Fusing Porcelain System	Dentsply Intl.	EIH	Class II	1995-11-02
K954743	Dermagran Wound Dressing Cleaner W/zinc	Derma Sciences, Inc.	FRO	Unclassified	1995-11-02
K954742	Dermagran Wet Dressing (Zinc-Saline)	Derma Sciences, Inc.	FRO	Unclassified	1995-11-02
K954740	Dermagran Wound Dressing	Derma Sciences, Inc.	FRO	Unclassified	1995-11-02
K954739	Dermagran Hydrophilic Ointment	Derma Sciences, Inc.	FRO	Unclassified	1995-11-02
K954738	Dermagran Hydrophilic Wound Dressing	Derma Sciences, Inc.	MGP	Unclassified	1995-11-02
K954602	Flexzan Wound Dressing	Dow Hickam Pharmaceuticals, Inc.	MGP	Unclassified	1995-11-02
K954440	Apex Tubing Set	Linvatec Corporation	HRX	Class II	1995-11-02
K954089	Endopath Open or Endoscopic Electrosugical Coagulation & Cutting Device	Ethicon Endo-Surgery Inc	GCJ	Class II	1995-11-02
K953720	Aesculap Caspar Plate & Screw System for Anterior Cervical Fusion	Aesculap Inc	KWQ	Class II	1995-11-02
K952442	Freedom Bath	Grand Traverse Technologies	ILJ	Class II	1995-11-02
K951247	Spiralgold & Spiraloxy Hollow Fiber Oxygenators	Baxter Healthcare Corporation	DTZ	Class II	1995-11-02
K950436	Witt Biomedical Series IV	Invivo Corporation	MHX	Class II	1995-11-02
K954741	Dermagran Went Dressing (Dextrose-Saline)	Derma Sciences, Inc.	MGQ	Unclassified	1995-11-01
K954664	Dermagran (Zinc Saline) Hydrogel Wound Dressing	Derma Sciences, Inc.	MGQ	Unclassified	1995-11-01
K954298	Virotrol IV	Blackhawk Biosystems, Inc.	JJY	Class I	1995-11-01
K954253	Storz S2060-C & Dp9040 Bipolar Ccord Adaptors	Storz Instrument Co.	GEI	Class II	1995-11-01
K954103	Tourni-Comp	Scandinavian Medical JW AB	KCY	Class I	1995-11-01
K953969	Preclude Dura Substitute	W. L. Gore & Associates, Inc.	GXQ	Class II	1995-11-01
K953668	Unscented Ultrathin Maxi Pad	Paragon Trade Brands, Inc.	HHD	Class I	1995-11-01
K953667	Unscented Curved Ultrathin Maxi Pads	Paragon Trade Brands, Inc.	HHD	Class I	1995-11-01
K953633	Unscented Menstrual Pad	Tendasoft, Inc.	HHD	Class I	1995-11-01
K954712	Intramedullary Hip Screw (Modification)	Smith & Nephew Richards, Inc.	KTT	Class II	1995-10-31
K954568	The Reiff Quantum Wheelchair, or Quantum Wheelchairs	Reif Wheelchairs and Accessories, Inc.	IOR	Class I	1995-10-31
K954485	6.5Mm Solid Cancellous Bone Screw	Ace Medical	HWC	Class II	1995-10-31
K953937	Liaison Computer Access & Environmental Control System	Apt Technology, Inc.	IQA	Class II	1995-10-31
K953887	Re-Usable Concentric Needle	Chalgren Enterprises, Inc.	IKT	Class II	1995-10-31
K953886	Re-Usable Monopolar Needle	Chalgren Enterprises, Inc.	IKT	Class II	1995-10-31
K953870	Acttrac Electronic Control Device for the Act & Act II Coagulation Instruments	Medtronic, Inc.	GKN	Class II	1995-10-31
K953442	Restore, Thermacells (Hot Pack I)	Neal Dunning Assoc., Inc.	IMD	Class I	1995-10-31
K953406	Ebi X Fix Dynafix System (Dfs)	Electro-Biology, Inc.	KTT	Class II	1995-10-31
K953397	Hex-Fix Field Fixator	Smith & Nephew Richards, Inc.	LXT	Class II	1995-10-31
K953334	Synthes Flexnail	Synthes (USA) Products LLC	HSB	Class II	1995-10-31
K953194	Lactosorb Bone Pin	Zimmer GmbH	HTY	Class II	1995-10-31
K953001	Tp-4K Screw Implant 3.3, 3.75, 4.0	Implant Center of the Palm Beaches	DZE	Class II	1995-10-31
K953000	Wide System Screw B5 Uncoated 5Mm, 6Mm	Implant Center of the Palm Beaches	DZE	Class II	1995-10-31
K952999	Uncoated Screw Implant 3.75, 4.0-B5	Implant Center of the Palm Beaches	DZE	Class II	1995-10-31
K952998	Tp Screw Implant 3.75, 4.0-B5	Implant Center of the Palm Beaches	DZE	Class II	1995-10-31
K952997	Pre Angulated Prosth: 15 Deg Angled, 25,& 25 Cone Angled	Implant Center of the Palm Beaches	DZE	Class II	1995-10-31
K952996	Ha/tp Coated Cylinder Implant 3.3,4.0	Implant Center of the Palm Beaches	DZE	Class II	1995-10-31
K952994	Tp-4 Wide Cylinder Implants	Implant Center of the Palm Beaches	DZE	Class II	1995-10-31
K952992	Prosthetics 4Mm	Implant Center of the Palm Beaches	DZE	Class II	1995-10-31
K952991	Wide Screw Ha-5B, Cyl-Ha-5	Implant Center of the Palm Beaches	DZE	Class II	1995-10-31
K952985	Wide Screws Tp-5B. Pros G5, Tools G5 or 17-4 Ss	Implant Center of the Palm Beaches	DZE	Class II	1995-10-31
K952700	Superslick	Bivona Medical Technologies	JOH	Class II	1995-10-31
K952032	Imagyn Hysteroscope Sheaths	Imagyn Medical, Inc.	HIH	Class II	1995-10-31