510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161953Substantially Equivalent

ReDe Mask

Tereopneuma, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161953 is the FDA 510(k) clearance record for ReDe Mask, a class II device, cleared for Tereopneuma on under FDA product code PRK (Device Indicating An Exhalation Event). FDA's definition for product code PRK reads: "To provide visual indication of each exhalation event". FDA records list one 510(k) clearance for Tereopneuma. As of , FDA records show no recalls naming K161953.

Clearance record

Decision date
Received
(214 days to decision)
Product code
PRK Device Indicating An Exhalation Event
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Tereopneuma 13223 Black Mountain Rd., Suite 1-224, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PRK

Trailing 12 months

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

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