510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003894Substantially Equivalent

Oracle Oral Mask

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

K003894 is the FDA 510(k) clearance record for ORACLE ORAL MASK, a class II device, cleared for Fisher & Paykel Healthcare, Ltd. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 86 510(k) clearances for Fisher & Paykel Healthcare, Ltd., from to . As of , FDA records show 6 recalls naming K003894.

Clearance record

Decision date
Received
(189 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Pl., East Tamaki, Auckland, NZ
510(k) summary
Summary
Third party review
No

Clearances, product code BZD

Trailing 12 months
11 clearances under product code BZD in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20260