# K110383: Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20

- Pathway: 510(k) (Traditional)
- Applicant: A Plus Medical
- Decided: Aug 1, 2011 after 172 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K831246 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093716: Babi Plus Infant Nasal Cannula System, A Plus Medical (2010) Summary page 1.
- K040366: Pressure Manifold, Model BC 110, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Recalls of this device
- Jun 14, 2019 · Class I · Z-0009-2020: Device vented gas below the stated pressure.
- May 30, 2019 · Class I · Z-0021-2020: Reports of pressure relief manifold venting gas below the standard pressure.
- May 30, 2019 · Class I · Z-0020-2020: Reports of pressure relief manifold venting gas below the standard pressure.
- May 30, 2019 · Class I · Z-0022-2020: Reports of pressure relief manifold venting gas below the standard pressure.

## Indications for use
Single patient use device intended for neonate, infant or child with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital critical care unit.

Source page: https://510kreport.com/device/K110383
Methodology: https://510kreport.com/methodology