510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123176Substantially Equivalent

ISO-Gard Clearair Mask

Teleflexmedical, Inc., Research Triangle Park NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123176 is the FDA 510(k) clearance record for ISO-GARD CLEARAIR MASK, a class II device, cleared for Teleflexmedical, Inc. on under FDA product code CBN (Apparatus, Gas-Scavenging). FDA records list 64 510(k) clearances for Teleflexmedical, Inc., from to . As of , FDA records show no recalls naming K123176.

Clearance record

Decision date
Received
(127 days to decision)
Product code
CBN Apparatus, Gas-Scavenging
Regulation
21 CFR 868.5430
Device class
Class II
Review panel
Anesthesiology
Applicant
Teleflexmedical, Inc. 2917 Weck Dr., Research Triangle Park NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBN

Trailing 12 months

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

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