510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252078Substantially Equivalent

BreathePal Bilevel (GFM50-MD2201)

Compal Electronics, Inc, Taipei City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252078 is the FDA 510(k) clearance record for BreathePal Bilevel (GFM50-MD2201), a class II device, cleared for Compal Electronics, Inc. on under FDA product code MNS (Ventilator, Continuous, Non-Life-Supporting). FDA records list 3 510(k) clearances for Compal Electronics, Inc., from to . As of , FDA records show no recalls naming K252078.

Clearance record

Decision date
Received
(258 days to decision)
Product code
MNS Ventilator, Continuous, Non-Life-Supporting
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Compal Electronics, Inc. # 581 And 581-1, Ruiguang Rd., Neihu Dist., Taipei City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNS

Trailing 12 months
3 clearances under product code MNS in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MNS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260