510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K083122Substantially Equivalent

Hospital Full Face Mask Non Vented, Model: Rt041

Fisher & Paykel Healthcare, Inc., East Tamaki, NZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083122 is the FDA 510(k) clearance record for HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041, a class II device, cleared for Fisher & Paykel Healthcare, Ltd. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 86 510(k) clearances for Fisher & Paykel Healthcare, Ltd., from to . As of , FDA records show no recalls naming K083122.

Clearance record

Decision date
Received
(133 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Pl., East Tamaki, NZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260