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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2583 of 3530

510(k) clearances, page 2583 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K894044	Actillume	Ambulatory Monitoring, Inc.	GWQ	Class II	1989-12-22
K894028	Ambulatory Infusion System and Accessories	Patient Solutions, Inc.	FRN	Class II	1989-12-22
K893874	Fujitens III	Altoona Medical Supply	GZQ	Class II	1989-12-22
K893705	Safe-1 Venous Reservoir	Polystan C/O Vitalcor, Inc.	DTN	Class II	1989-12-22
K893704	Safe-1	Polystan C/O Vitalcor, Inc.	DTZ	Class II	1989-12-22
K890624	Tissue Oxygen Monitor System, Model II	Baxter Healthcare Corporation	CCE	Class II	1989-12-22
K885161	Voss Vein Clamp	voss medical products	DXC	Class II	1989-12-22
K896647	Gyroview Hr High Resolution Workstation	Philips North America LLC	LNH	Class II	1989-12-21
K896485	Modified Island TENS Disp. Electrode for Snap Conn	Empi	GXY	Class II	1989-12-21
K896167	Ps Medical Csf-On/off Flushing Reservoir	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1989-12-21
K895875	Model 4070 Temperature Monitor	Mallinckrodt Anesthesia Products	FLL	Class II	1989-12-21
K895798	Silcot Copal Cavity Varnish	Specialites Septodont	EMA	Class II	1989-12-21
K895754	Latex Patient Examination Gloves	Frontline Latex Products Pvt., Ltd.	LYY	Class I	1989-12-21
K895750	Hema-Primer	Parkell, Inc.	KLE	Class II	1989-12-21
K895748	Bicarbonate for Manual/automated Applications	Catachem, Inc.	KHS	Class II	1989-12-21
K895714	Ortho-Kev Appliance Reinforcing System	American Orthodontics	EBI	Class II	1989-12-21
K894946	Platelia Rubella Igg Kit	Kallestad Diag, A Div. of Erbamont, Inc.	LFX	Class II	1989-12-21
K894871	Wiltek Biliary Stent Set	Wiltek Medical, Inc.	FGE	Class II	1989-12-21
K894870	Wiltek Nasal Biliary Drainage Set	Wiltek Medical, Inc.	BSS	Class II	1989-12-21
K894869	Wiltek Polypectomy Snare	Wiltek Medical, Inc.	FDI	Class II	1989-12-21
K894868	Wiltek Varices Injection Needle	Wiltek Medical, Inc.	FBK	Class II	1989-12-21
K894867	Wiltek E.r.c.p. Catheter	Wiltek Medical, Inc.	FGE	Class II	1989-12-21
K894866	Wiltek Stone Extractor	Wiltek Medical, Inc.	LQR	Class II	1989-12-21
K894865	Wiltek Balloon Stone Extractor	Wiltek Medical, Inc.	LQR	Class II	1989-12-21
K894863	Wiltek Cytology Brush	Wiltek Medical, Inc.	FDX	Class II	1989-12-21
K894862	Wiltek Grasping Forceps	Wiltek Medical, Inc.	OCZ	Class II	1989-12-21
K894861	Wiltek Papillotome	Wiltek Medical, Inc.	KNS	Class II	1989-12-21
K894860	Wiltek Gastric Feeding Tube	Wiltek Medical, Inc.	FPD	Class II	1989-12-21
K894653	No. 87500-Nuport Peg Gastrostomy Tube Kit 22 Fr	Superior Biosystems, Inc.	KGC	Class II	1989-12-21
K894058	Isodent	Eurodent, Inc.	EIA	Class I	1989-12-21
K893632	Patient Examination Gloves	Pro Asia, Inc.	LYY	Class I	1989-12-21
K892817	Heated Respiratory Humidifier	Fisher & Paykel Electronics, Ltd.	BTT	Class II	1989-12-21
K892633	Patient Examination Gloves (Latex)	Gobo Intl.	LYY	Class I	1989-12-21
K891346	Artech Type Ss Submerged Screw Implant	Artech Corp.	DZE	Class II	1989-12-21
K890999	Modified Qdr-1000 X-Ray Bone Densitometer	Hologic, Inc.	KGI	Class II	1989-12-21
K896489	Toyosuya Latex Examination Gloves	Toyosuya Sdn Bhd	LYY	Class I	1989-12-20
K896443	Myopore(tm) Unipolar Models 1117 & 1118 Pace Leads	Possis Medical, Inc.	DTB	Class III	1989-12-20
K896411	Revised Patient Examination Gloves	Pt. Trihasta Loka Persada	LYY	Class I	1989-12-20
K895836	Inflation Pro II	Baxter Healthcare Corporation	MAV	Class II	1989-12-20
K895758	Plastic Tooth Reinforcement Kit	Nanzee Dental Products	EBL	Class I	1989-12-20
K895447	Endocardial Screw-in Lead Model 1020T	Pacesetter Systems	DTB	Class III	1989-12-20
K894900	Latex Patient Examination Gloves	Fujian Ming Sheng Chemistry	LYY	Class I	1989-12-20
K894492	Nka Model Sec-3102 Cardiac Stimulator	Nihon Kohden America Inc	DRO	Class II	1989-12-20
K894085	Talladium Tilite Ceramic Alloy	Talladium Inc	EJH	Class II	1989-12-20
K893877	Biochem 3100 Oximeter	Biochem International, Inc.	DQO	Class II	1989-12-20
K893800	Sequel (Casting Alloy for Porcelain-Fused-Metal)	Deringer-Ney, Inc.	EJT	Class II	1989-12-20
K892194	Patient Examination Gloves (Latex)	Pao Chen Industrial Co., Ltd.	LYY	Class I	1989-12-20
K896550	Tdx(r) Barbiturates II Assay	Abbott Medical	DIS	Class II	1989-12-19
K896144	Autoscan, Autostrip and Autocontrol	Cascade Medical, Inc.	CGA	Class II	1989-12-19
K896007	Cobas Ready	Roche Diagnostic Systems, Inc.	JJQ	Class I	1989-12-19