510(k) · Cleared
Recalled · Class II · 2022Precision Flow (R) - Heliox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vapotherm, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Oct 7, 2011 as substantially equivalent to K090781 (Precision Medical, Inc., 2009) and 2 other predicates after a 116-day review. Its family tree reaches back 6 generations to 1994. It has been recalled once.
- Decided
- Oct 7, 2011
- Review
- 116 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K935370 (1994). 16 ancestors in all, the oldest K911962 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 5 generations backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- 4 generations backK023565 OxicheckCaradyne, Ltd. · 2003
- 3 generations backK040484 MAXO2+, Model a and AEMaxtec, Inc. · 2004
- 2 generations backK063488 MAXO2 CUMaxtec, Inc. · 2007
- 1 generation backK072845 Precision FlowVapotherm, Inc. · 2008 · Recalled
- This deviceK111640 Precision Flow (R) - HelioxVapotherm, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −5 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| −4 | K023565 | Oxicheck | Caradyne, Ltd. | 2003 | — |
| −3 | K040484 | MAXO2+, Model a and AE | Maxtec, Inc. | 2004 | — |
| −2 | K063488 | MAXO2 CU | Maxtec, Inc. | 2007 | — |
| −1 | K072845 | Precision Flow | Vapotherm, Inc. | 2008 | 8 |
| 0 (this device) | K111640 | Precision Flow (R) - Heliox | Vapotherm, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTT device
- #1 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula…score 16.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090781 | HELIO2 BlenderSummary page 1…Humidifier, Respiratory Gas (Direct Patient Interface) Predicate Device Primary Device: Precision Medical, Inc. HeiioxlOxygen Blender, K090781 Secondary Device: Precision Flow® - Air, K072845 The Precision Medical device is a mechanical device and the Precision… | 2009 |
| * | K072845 | Precision FlowSummary page 1…) Predicate Device Primary Device: Precision Medical, Inc. HeiioxlOxygen Blender, K090781 Secondary Device: Precision Flow® - Air, K072845 The Precision Medical device is a mechanical device and the Precision Flow® device is electron ic/mechan icalI device.… | 2008 |
| * | K053232 | Precision Blender | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2022 | Class II | Z-1272-2023 | Nonconforming Material/Component | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K090781.
How does its category compare?
All BTT devicesBTT Humidifier, Respiratory Gas, (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BTT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTT
104in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTT
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BTT
1,743in 2025
MAUDE reports naming product code BTT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 73 | 1 | 365 |
| 2008 | 4 | 199 | 1 | 456 |
| 2009 | 1 | — | 0 | 558 |
| 2010 | 4 | 113 | 2 | 562 |
| 2011 | 3 | 116 | 1 | 665 |
| 2012 | 2 | — | 0 | 583 |
| 2013 | 6 | 171 | 0 | 718 |
| 2014 | 7 | 231 | 5 (4) | 718 |
| 2015 | 1 | — | 0 | 670 |
| 2016 | 3 | 157 | 0 | 1,094 |
| 2017 | 3 | 303 | 0 | 1,007 |
| 2018 | 2 | — | 0 | 918 |
| 2019 | 1 | — | 0 | 894 |
| 2020 | 2 | — | 0 | 1,188 |
| 2021 | 2 | — | 0 | 1,510 |
| 2022 | 3 | 290 | 0 | 749 |
| 2023 | 7 | 258 | 0 | 716 |
| 2024 | 7 | 219 | 0 | 501 |
| 2025 | 4 | 104 | 1 | 1,743 |
| 2026 | 4 | 184 | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111640: Precision Flow (R) - Heliox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111640
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026