510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191282Substantially Equivalent

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family

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

K191282 is the FDA 510(k) clearance record for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family, a class II device, cleared for Pentax of America, Inc. on under FDA product code PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement). FDA's definition for product code PEA reads: "Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement". FDA records list 72 510(k) clearances for Pentax of America, Inc., from to . As of , FDA records show no recalls naming K191282.

Clearance record

Decision date
Received
(179 days to decision)
Product code
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pentax of America, Inc. 3 Paragon Dr.,, Montvale NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEA

Trailing 12 months

FDA records hold no clearances under product code PEA in the trailing twelve months.

FDA records show no clearances under product code PEA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PEA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260