510(k) · Cleared
Cleared0.9.% Sodium Chloride Inhalation Solution, 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 Jan 21, 1998 as substantially equivalent to K884359 (Automatic Liquid Packaging, Inc., 1988) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Jan 21, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K870332 (1987). 2 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 deviceK974056 0.9.% Sodium Chloride Inhalation Solution, UspHolopack International, LP · 1998
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) | K974056 | 0.9.% Sodium Chloride Inhalation Solution, Usp | Holopack International, LP | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K884359 | Unit Dose 3% Sodium Chloride Solution for Inhala.Summary page 2…ate Devices to which Equivalence is Claimed There are several comparable devices manufactured prior to 1976 and/or those to which Substantial Equivalence is claimed. K884359 Unit Dose 0.45%; 0.9% ; 3% Sodium Chloride Solution for Inhalation in 3, 5 and 15mL containers K870332 Automatic Liquid Packagi… | 1988 |
| * | K870332 | Prefilled Respiratory Therapy VialsSummary page 2…1976 and/or those to which Substantial Equivalence is claimed. K884359 Unit Dose 0.45%; 0.9% ; 3% Sodium Chloride Solution for Inhalation in 3, 5 and 15mL containers K870332 Automatic Liquid Packaging, Inc. 2200 W. Lake Shore Drive - Woodstock, IL 60096 'K8703320 Travenol Laboratories ( pre-1976) W… | 1987 |
| * | — | Travenol Laboratories (pre-1976) Named without a submission number | |
| * | — | Wyeth Laboratories, Inc. (pre-1976) Named without a submission number | |
| * | — | Respiratory Therapy Vials Sodium Chloride Inhalation Solution 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 2 ancestors has a recall.
- 1 other device also cites its predicate K884359.
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/K974056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974056: 0.9.% Sodium Chloride Inhalation Solution, Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974056
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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