# K072845: Precision Flow

- Pathway: 510(k) (Traditional)
- Applicant: Vapotherm, Inc.
- Decided: Jul 17, 2008 after 287 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K935370 (1994). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000401: Vapotherm, Model 2000I, Vapotherm, Inc. (2000) Summary page 1.
- K042245: Vapotherm Model#2000I, 200H, Vapotherm, Inc. (2004) Summary page 1.
- K063488: MAXO2 CU, Maxtec, Inc. (2007) Summary page 1.
- K911962: Bird Sentry Air/Oxygen Microblender, Bird Products Corp. (1991) Summary page 1.

## Cited in the summary but kept off the family tree
- K014245: Jetsonic 2000, Deldent, Ltd. (2002). Our reading of the summary gave K014245, FDA’s number for Jetsonic 2000 (Deldent, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Vapotherm 2000i and 2000h”. Kept off the family tree.

## Most influential descendants
- K254078: HVT 2.0 (2026), 0 descendants of its own
- K111640: Precision Flow (R) - Heliox (2011), 0 descendants of its own

## Recalls of this device
- Aug 13, 2014 · Class II · Z-2700-2014: Disposable Patient Circuit that allows water to leak into the center gas lumen
- Aug 13, 2014 · Class II · Z-2705-2014: Disposable Patient Circuit that allows water to leak into the center gas lumen
- Aug 13, 2014 · Class II · Z-2704-2014: Disposable Patient Circuit that allows water to leak into the center gas lumen
- Aug 13, 2014 · Class II · Z-2706-2014: Water may leak into the center gas lumen of the Patient Circuit
- Aug 13, 2014 · Class II · Z-2701-2014: Disposable Patient Circuit that allows water to leak into the center gas lumen
- Aug 13, 2014 · Class II · Z-2699-2014: Disposable Patient Circuit that allows water to leak into the center gas lumen
- Aug 13, 2014 · Class II · Z-2702-2014: Disposable Patient Circuit that allows water to leak into the center gas lumen
- Aug 13, 2014 · Class II · Z-2703-2014: Disposable Patient Circuit that allows water to leak into the center gas lumen

## Indications for use
Precision Flow MT is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to a blended medical air/oxygen mixture and assures the integrity of the precise airloxygen mixture via an integral oxygen analyzer. The flow rates may be from I to 40 liters per minute via nasal cannula.

Source page: https://510kreport.com/device/K072845
Methodology: https://510kreport.com/methodology