# K111640: Precision Flow (R) - Heliox

- Pathway: 510(k) (Traditional)
- Applicant: Vapotherm, Inc.
- Decided: Oct 7, 2011 after 116 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935370 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090781: HELIO2 Blender, Precision Medical, Inc. (2009) Summary page 1.
- K072845: Precision Flow, Vapotherm, Inc. (2008) Summary page 1.
- K053232: Precision Blender, Precision Medical, Inc. (2006)

## Recalls of this device
- Dec 16, 2022 · Class II · Z-1272-2023: There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.

## Indications for use
The Precision Flow@ - Heliox is intended to warm and add moisture to breathing gases from an external source for administration to neonate/infant, pediatric and adult patients in the hospital and sub-acute institutions. It adds heat and moisture to a blended medical heliox (79% helium, 210/% oxygen)/oxygen mixture and assures the integrity of the precise heliox (79% helium, 21%/ oxygen)/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

Source page: https://510kreport.com/device/K111640
Methodology: https://510kreport.com/methodology