510(k) · Cleared
ClearedSterile Water for Inhalation in 1L Flexoval ® bottles.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hometa, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Aug 3, 2023 as substantially equivalent to K090915 (Cardinal Health, Inc., 2009) after a 251-day review. Its family tree reaches back 2 generations to 1976. 1 later device descends from it.
- Decided
- Aug 3, 2023
- Review
- 251 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K760584 (1976). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK760584 U-Mid Prefilled Humidifier (500CC)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1976
- 1 generation backK090915 Sterile Water for Inhalation Flex Bag, UspCardinal Health, Inc. · 2009
- This deviceK223551 Sterile Water for Inhalation in 1L Flexoval ® bottles.Hometa, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK242717 Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242717Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K760584 | U-Mid Prefilled Humidifier (500CC) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976 | — |
| −1 | K090915 | Sterile Water for Inhalation Flex Bag, Usp | Cardinal Health, Inc. | 2009 | — |
| 0 (this device) | K223551 | Sterile Water for Inhalation in 1L Flexoval ® bottles. | Hometa, Inc. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K090915 | Sterile Water for Inhalation Flex Bag, UspSummary page 5…lent: Predicate Device Applicant 510(k) No Sterile Water for Inhalation Flex Bag, USP Cardinal Health Inc K090915 DEVICE DESCRIPTION The Sterile Water for Inhalation is provided in a Flexoval® bottle which is a flexible plastic bottle with a… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | 2025 | 0 |
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?
- The line of descent spans 47 years and passes through 3 companies; a new generation was cleared every 33.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K242717 (Laboratorios Biogalenic S.A. DE C.V., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K090915.
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. 2023, 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 Flexoval® Bottle 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 by qualified staff.
The Sterile Water for Inhalation is intended for use in all patient populations including adults, pediatrics, infants and neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223551: Sterile Water for Inhalation in 1L Flexoval ® bottles..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223551
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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