510(k) · Cleared
ClearedSterile Water for Inhalation Flex Bag, Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Nov 18, 2009 as substantially equivalent to K780381 (Travenol Laboratories, S.A., 1978) and 2 other predicates after a 231-day review. Its family tree reaches back 1 generation to 1976. 3 later devices descend from it.
- Decided
- Nov 18, 2009
- Review
- 231 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K760584 (1976). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK760584 U-Mid Prefilled Humidifier (500CC)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1976
- This deviceK090915 Sterile Water for Inhalation Flex Bag, UspCardinal Health, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK223551 Sterile Water for Inhalation in 1L Flexoval ® bottles.Hometa, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK251419 Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V. · 2026
- Descendant · 2 generations on · 0 of its ownK242717 Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V. · 2025
Most influential descendants
Showing 3 of 3 · See all- K223551Sterile Water for Inhalation in 1L Flexoval ® bottles.Hometa, Inc. · 2023 · cites it directly1descendant
- K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V. · 2026 · cites it directly0descendants
- K242717Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760584 | U-Mid Prefilled Humidifier (500CC) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976 | — |
| 0 (this device) | K090915 | Sterile Water for Inhalation Flex Bag, Usp | Cardinal Health, Inc. | 2009 | — |
| +1 | K223551 | Sterile Water for Inhalation in 1L Flexoval ® bottles. | Hometa, Inc. | 2023 | — |
| +1 | K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2026 | — |
| +2 | K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K780381 | Respiratory Therapy Solutions - FlexibleSummary page 1…Class II Classification Panel Anesthesiology Predicate Device The predicate device(s) are K780381 Respiratory Therapy Solutions - Flexible K853146 Prefilled Respiratory Therapy Humidifier… | 1978 |
| * | K853146 | Respir Ther Humid Contain Sterile Water for UspSummary page 1…Device The predicate device(s) are K780381 Respiratory Therapy Solutions - Flexible K853146 Prefilled Respiratory Therapy Humidifier containing Sterile Water for Inhalation USP… | 1985 |
| * | K760584 | U-Mid Prefilled Humidifier (500CC)Summary page 1…K853146 Prefilled Respiratory Therapy Humidifier containing Sterile Water for Inhalation USP K760584 U Mid Prefilled Humidifier Becton Dickinson Vacutainer Systems Pre-Analytic Device Desc… | 1976 |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K223551 (Hometa, Inc., 2023) has gone furthest, with 1 descendant of its own.
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. 2009, 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 Sterile Water for Inhalation Flex Bag USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers It is intended to be used in institutional and non institutional care settings
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090915: Sterile Water for Inhalation Flex Bag, Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090915
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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