510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K113873Substantially Equivalent

Pentax Epk-I5020 Video Processor

PENTAX of America, Inc., West Cadwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113873 is the FDA 510(k) clearance record for PENTAX EPK-I5020 VIDEO PROCESSOR, a class II device, cleared for Pentax of America, Inc. on under FDA product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology). FDA's definition for product code FET reads: "To allow for visualization of body cavities through an endoscope by projecting images to a monitor". FDA records list 72 510(k) clearances for Pentax of America, Inc., from to . As of , FDA records show no recalls naming K113873.

Clearance record

Decision date
Received
(175 days to decision)
Product code
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pentax of America, Inc. 1129 Bloomfield Ave., West Cadwell NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FET

Trailing 12 months
3 clearances under product code FET in the twelve months to November 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FET, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260
November 20260