510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K936046Substantially Equivalent

Sigma Elite

Penlon, Ltd., Abingdon Ox, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K936046 is the FDA 510(k) clearance record for SIGMA ELITE, a class II device, cleared for Penlon, Inc. on under FDA product code CAD (Vaporizer, Anesthesia, Non-Heated). FDA records list 22 510(k) clearances for Penlon, Inc., from to . As of , FDA records show no recalls naming K936046.

Clearance record

Decision date
Received
(319 days to decision)
Product code
CAD Vaporizer, Anesthesia, Non-Heated
Regulation
21 CFR 868.5880
Device class
Class II
Review panel
Anesthesiology
Applicant
Penlon, Inc. Abingdon Ox 14 3ph, Abingdon Ox, GB
510(k) summary
Summary
Third party review
No

Clearances, product code CAD

Trailing 12 months

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

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