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 2130 of 3531

510(k) clearances, page 2130 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941790	Pro-Tect Safety Dressing	Pro-Tect Medical Products, Inc.	MGP	Unclassified	1995-01-12
K941789	Pro-Tect Trauma Pak	Pro-Tect Medical Products, Inc.	MGP	Unclassified	1995-01-12
K940455	Lateral Flexion Machine	Rehab, Inc.	BXB	Class I	1995-01-12
K946154	Mala Latex Exam Gloves and Scan-Sub	Lowenkamp Intl., Inc.	LYY	Class I	1995-01-11
K945978	Tubing, Noninvasive	Endoscopic Technologies, Inc.	GAZ	Class II	1995-01-11
K945830	Duflex Conforming Bandage (Sterile/non-Sterile)	Dumex Medical Surgical Products, Ltd.	EFQ	Unclassified	1995-01-11
K945414	Ristocetin Cofactor Assay Kit	Chrono-Log Corp.	GGP	Class II	1995-01-11
K945220	Amalgam Carrier	Buffalo Dental Mfg Co Inc	EKI	Class I	1995-01-11
K945142	Polysil (Vinyl Polysiloxan Impression Material)	Scican Ltd.	ELW	Class II	1995-01-11
K945103	Temp and Permanent Neuro Leads (Various Models)	Medtronic, Inc.	GZB	Class II	1995-01-11
K945031	Royalshield Non-Sterile Powder-Free	Shield Gloves Manufacturer (M) Sdn Bhd	LYY	Class I	1995-01-11
K944757	Piston Syringes	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1995-01-11
K944072	Olympus Nasal and Sinus Endoscopes	OLYMPUS Corporation of the Americas	EOB	Class II	1995-01-11
K940015	Snoring Microphone, Sm1	Pro-Tech, Inc.	MNR	Class II	1995-01-11
K931020	Heart 1001	Aerotel Ltd.	DXH	Class II	1995-01-11
K926567	Baxter Ca Dialyzer	Baxter Healthcare Corporation	FJI	Class II	1995-01-11
K925406	Biliary Endoprostheses W/unistep Delivery System	Schneider Intl., Ltd.	FGE	Class II	1995-01-11
K921525	Hip Joint Metal/polymer Semi-Constrained Prothesis	Implant Technology, Inc.	LPH	Class II	1995-01-11
K921478	Guardport	Health Improvement Assoc.	KNT	Class II	1995-01-11
K940128	Cat-400Ul Penile Plethysmograph	Farrall Instruments, Inc.	LIL	Unclassified	1995-01-10
K936115	Cat-600 Penile Plethysmograph	Farrall Instruments, Inc.	LIL	Unclassified	1995-01-10
K946173	Stainless Steel, Gut, Poly (Glycolide/l-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk	Ethicon, Inc	GAQ	Class II	1995-01-09
K945823	Power Rangers Sunglasses	Avon Products, Inc.	HQY	Class I	1995-01-09
K945659	Blackstar(tm) Star System	Xomed-Treace, Inc.	ERL	Class II	1995-01-09
K944568	Sunglasses	Great Field Industries Co., Ltd.	HQY	Class I	1995-01-09
K943569	Stryker Total Performance System	Stryker Corp.	ERL	Class II	1995-01-09
K943557	Imagen	Dako Diagnostics, Ltd.	GQS	Class I	1995-01-09
K943454	Plato 3300/1300	Rosys, Inc.	JJQ	Class I	1995-01-09
K942537	Paramount Cemented Hip Stem Prothesis	Depuy, Inc.	JDI	Class II	1995-01-09
K942300	Silkon Titanium Cable System	American Medical Electronics, Inc.	JDQ	Class II	1995-01-09
K942267	Dried Gram-Positive Mic/combo Panels/cefmetazole	Baxter Diagnostics, Inc.	JWY	Class II	1995-01-09
K942089	Microdilution/loracarbef Panels	Baxter Diagnostics, Inc.	JWY	Class II	1995-01-09
K942045	Insyte Introducer Catheter	Becton Dickinson Vascular Access, Inc.	FOZ	Class II	1995-01-09
K941871	Lspi Automatic Ventilator, Model Av3000-100	Life Support Products, Inc.	BTL	Class II	1995-01-09
K941870	Lspi Automatic Ventilator, Model Av2000-100	Life Support Products, Inc.	BTL	Class II	1995-01-09
K935011	Swimex Multidepth Pool (Model 600T)	Swimex Systems	BXB	Class I	1995-01-09
K933958	Richards Total Knee System	Smith & Nephew Richards, Inc.	JWH	Class II	1995-01-09
K922216	Flexiflo Tube Placement Verifier	Abbott Medical	KNT	Class II	1995-01-09
K944965	Optilite VI Fiberoptic Accessories	Xintec Corporation	GEX	Class II	1995-01-06
K944900	Therapep	Dhd Diemolding Healthcare Div.	BWF	Class II	1995-01-06
K944704	Optilite (Tm) VII Fiberoptic Accessories Rotalase (Tm) Angle Delivery Systemsn and Accessories	Xintec Corporation	GEX	Class II	1995-01-06
K944132	P.f.c. Total Hip System	Johnson & Johnson Professionals, Inc.	KWY	Class II	1995-01-06
K943071	The Titanium Fixation System	Biomedics	JEY	Class II	1995-01-06
K940415	Horizon 9000 Ws	Mennen Medical, Inc.	DXG	Class II	1995-01-06
K936273	Stereo Opsis Camera System 3-D Distal Cam and 3-D Distal Cam 360	Baxter Healthcare Corporation	HET	Class II	1995-01-06
K932993	Intrauterine Catheter and Introducer	Conceptus, Inc.	MFD	Class II	1995-01-06
K946002	Origin Preperitoneal Dissection Balloon System (Pdbs)--Extra	Origin Medsystems, Inc.	GEX	Class II	1995-01-05
K945840	Bunny Sunglasses	Tony (U.S.A.), Inc.	HQY	Class I	1995-01-05
K945819	Sunglasses	Walmart Stores	HQY	Class I	1995-01-05
K945818	Sunglasses	Walmart Stores	HQY	Class I	1995-01-05