510(k) · Cleared
ClearedSterile Water for Inhalation, Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Holopack International, LP · CAF Nebulizer (Direct Patient Interface)
Cleared on Aug 28, 1997 as substantially equivalent to K871618 (Automatic Liquid Packaging, Inc., 1987) and 2 other predicates after a 58-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Aug 28, 1997
- Review
- 58 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K870332 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK870332 Prefilled Respiratory Therapy VialsAutomatic Liquid Packaging, Inc. · 1987
- This deviceK972467 Sterile Water for Inhalation, UspHolopack International, LP · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870332 | Prefilled Respiratory Therapy Vials | Automatic Liquid Packaging, Inc. | 1987 | — |
| 0 (this device) | K972467 | Sterile Water for Inhalation, Usp | Holopack International, LP | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 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 CAF? 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 CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K871618 | Prefilled Sterile Water for Inhalation, UspSummary page 3…icate Devices to which Equivalence is Claimed There are several comparable devices manufactured prior to 1976 and/or those to which Substantial Equivalence is claimed. K871618 Prefilled Sterile Water for Inhalation, USP Automatic Liquid Packaging, Inc. 2200 W. Lake Shore Drive Woodstock, 1L 60096 K87033… | 1987 |
| * | K870332 | Prefilled Respiratory Therapy VialsSummary page 3…h Substantial Equivalence is claimed. K871618 Prefilled Sterile Water for Inhalation, USP Automatic Liquid Packaging, Inc. 2200 W. Lake Shore Drive Woodstock, 1L 60096 K870332 Travenol Laboratories ( pre-1976) Wyeth Laboratories, Inc. (pre-1976) Respiratory Therapy Vials Kg881184 Sterile Water for Inhal… | 1987 |
| * | K881184 | Intertech Sterile Water for InhalationSummary page 3…Packaging, Inc. 2200 W. Lake Shore Drive Woodstock, 1L 60096 K870332 Travenol Laboratories ( pre-1976) Wyeth Laboratories, Inc. (pre-1976) Respiratory Therapy Vials Kg881184 Sterile Water for Inhalation Delmed-Intertech Sterile Water for Inhalation, USP Dey Laboratories, Inc. Concord, CA 94518 4, De… | 1988 |
| * | — | Sterile Water for Inhalation, USP — Dey Laboratories, Inc. Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, 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 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972467 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972467: Sterile Water for Inhalation, Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972467
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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