# K040862: Guardian Neonate Cpap/Humidification System

- Pathway: 510(k) (Traditional)
- Applicant: Caradyne, Ltd.
- Decided: Jun 30, 2004 after 89 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000401 (2000). 2 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011516: Infant Flow System, Model M672P, Eme (Electro Medical Equipment), Ltd. (2001) Summary page 1.
- K000401: Vapotherm, Model 2000I, Vapotherm, Inc. (2000) Summary page 1.

## Most influential descendants
- K042245: Vapotherm Model#2000I, 200H (2004), 6 descendants of its own
- K072845: Precision Flow (2008), 2 descendants of its own
- K254078: HVT 2.0 (2026), 0 descendants of its own
- K193411: O2asis Personal Oxygen Humidifier (2020), 0 descendants of its own
- K111640: Precision Flow (R) - Heliox (2011), 0 descendants of its own

## Recalls of this device
- Dec 27, 2005 · Not classified · Z-0717-06: Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.
- Sep 19, 2005 · Not classified · Z-1191-06: Gas input pressures over 62 psi may cause CPAP pressure oscillation

## Indications for use
Intended to provide CPAP for use in hospitals to treat newborns and infants less than 5kg body weight with RDS or which are recovering from RDS. (Respiratory Distress Syndrome) May or may not include humidification capabilities

Source page: https://510kreport.com/device/K040862
Methodology: https://510kreport.com/methodology