510(k) · Cleared
Recalled · Class II · 2014Precision Flow
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 Jul 17, 2008 as substantially equivalent to K000401 (Vapotherm, Inc., 2000) and 3 other predicates after a 287-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 17, 2008
- Review
- 287 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 8
- Predicates
- 5
Its longest line of descent runs back 5 generations to K935370 (1994). 12 ancestors in all, the oldest K911962 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 4 generations backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- 3 generations backK023565 OxicheckCaradyne, Ltd. · 2003
- 2 generations backK040484 MAXO2+, Model a and AEMaxtec, Inc. · 2004
- 1 generation backK063488 MAXO2 CUMaxtec, Inc. · 2007
- This deviceK072845 Precision FlowVapotherm, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK254078 HVT 2.0Vapotherm, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK111640 Precision Flow (R) - HelioxVapotherm, Inc. · 2011 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −4 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| −3 | K023565 | Oxicheck | Caradyne, Ltd. | 2003 | — |
| −2 | K040484 | MAXO2+, Model a and AE | Maxtec, Inc. | 2004 | — |
| −1 | K063488 | MAXO2 CU | Maxtec, Inc. | 2007 | — |
| 0 (this device) | K072845 | Precision Flow | Vapotherm, Inc. | 2008 | — |
| +1 | K254078 | HVT 2.0 | Vapotherm, Inc. | 2026 | — |
| +1 | K111640 | Precision Flow (R) - Heliox | Vapotherm, Inc. | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2026 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000401 | Vapotherm, Model 2000ISummary page 1…thesiology Panel (868.5450) Class II C. Product Code BTT D. Predicate Devices Vapotherm, Inc. 2000i& 2000h K000401, K0142245, K042245 Medtec Oxygen Sensor K063488 Bird Products Air… | 2000 |
| Kept off the family tree | K014245 | FDA’s K014245 is Jetsonic 2000 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. | 2002 |
| * | K042245 | Vapotherm Model#2000I, 200HSummary page 1…68.5450) Class II C. Product Code BTT D. Predicate Devices Vapotherm, Inc. 2000i& 2000h K000401, K0142245, K042245 Medtec Oxygen Sensor K063488 Bird Products Air-Oxygen Blender… | 2004 |
| * | K063488 | MAXO2 CUSummary page 1…Predicate Devices Vapotherm, Inc. 2000i& 2000h K000401, K0142245, K042245 Medtec Oxygen Sensor K063488 Bird Products Air-Oxygen Blender K911962 198 Log Canoe Circle Stevensville, MD 21666… | 2007 |
| * | K911962 | Bird Sentry Air/Oxygen MicroblenderSummary page 1…000h K000401, K0142245, K042245 Medtec Oxygen Sensor K063488 Bird Products Air-Oxygen Blender K911962 198 Log Canoe Circle Stevensville, MD 21666 T 410.604.3977 F 410.604.3978 www.vtherm.com… | 1991 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2014 | Class II | Z-2700-2014 | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Class II | Z-2705-2014 | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Class II | Z-2704-2014 | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Class II | Z-2706-2014 | Process control | Water may leak into the center gas lumen of the Patient Circuit |
| Aug 13, 2014 | Class II | Z-2701-2014 | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Class II | Z-2699-2014 | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Class II | Z-2702-2014 | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Class II | Z-2703-2014 | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K254078 (Vapotherm, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K000401.
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. 2008, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072845: Precision Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072845
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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