510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110383Substantially Equivalent

Babi*plus Pressure Relief Manifold - 10Cm H20, 12.5Cm H20, 15Cm H20

A Plus Medical, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110383 is the FDA 510(k) clearance record for BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20, a class II device, cleared for A Plus Medical on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 7 510(k) clearances for A Plus Medical, from to . As of , FDA records show 4 recalls naming K110383.

Clearance record

Decision date
Received
(172 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
A Plus Medical 5431 Avenida Encinas, Carlsbad CA
510(k) summary
Summary PDF
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