510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212201Substantially Equivalent

PENTAX Medical Auto Leakage Tester SHA-P6

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

K212201 is the FDA 510(k) clearance record for PENTAX Medical Auto Leakage Tester SHA-P6, a class II device, cleared for Pentax of America, Inc. on under FDA product code PCV (Endoscopic Leak Tester). FDA's definition for product code PCV reads: "An endoscopic leak tester automatically detects leaks from endoscopes, without requiring visual observation for bubbles when the device is immersed in water, by assessing differences in air pressure inside the pressurized endoscope". FDA records list 72 510(k) clearances for Pentax of America, Inc., from to . As of , FDA records show no recalls naming K212201.

Clearance record

Decision date
Received
(79 days to decision)
Product code
PCV Endoscopic Leak Tester
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 PCV

Trailing 12 months

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

FDA records show no clearances under product code PCV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PCV, 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