510(k) · Cleared
Cleared3ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steripak, Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 2, 1998 as substantially equivalent to K840943 (Autovage, 1984) after a 90-day review. Its family tree reaches back 1 generation to 1984. 1 of the 6 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Jun 2, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K840943 (1984). 4 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK840943 Endo-JectAutovage · 1984
- This deviceK980829 3ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution…Steripak, Ltd. · 1998
- Descendant · cites it directly · 3 of its ownK113033 Sodium Chlorde Inhalation Solution, 0.9% Usp-3MLNephron Pharmaceuticals Corp. · 2012
- Descendant · 2 generations on · 1 of its ownK142153 Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution…Teleflexmedical, Inc. · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK231058 Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP · 2024
- Descendant · 2 generations on · 0 of its ownK130091 PulmosalPharmacaribe · 2013 · Recalled
Class I recalls in this family
- K142153 Hudson Rci Addipak Unit Dose Vial, 0.9% Full…2 generations on · 2015
Most influential descendants
Showing 4 of 4 · See all- K113033Sodium Chlorde Inhalation Solution, 0.9% Usp-3MLNephron Pharmaceuticals Corp. · 2012 · cites it directly3descendants
- K142153Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15MLTeleflexmedical, Inc. · 2015 · 2 generations on1descendant
- K231058Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP · 2024 · 3 generations on0descendants
- K130091PulmosalPharmacaribe · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840943 | Endo-Ject | Autovage | 1984 | — |
| 0 (this device) | K980829 | 3ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution Usp | Steripak, Ltd. | 1998 | — |
| +1 | K113033 | Sodium Chlorde Inhalation Solution, 0.9% Usp-3ML | Nephron Pharmaceuticals Corp. | 2012 | — |
| +2 | K142153 | Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution… | Teleflexmedical, Inc. | 2015 | Class I |
| +3 | K231058 | Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP | 2024 | — |
| +2 | K130091 | Pulmosal | Pharmacaribe | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2024 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K840943 | Endo-JectSummary page 1…equivalence claim is Dey’s 3 mL 0.9% Sodium Chloride Inhalation Solution USP. This product is distributed by Dey under Automatic Liquid Packaging, Incorporated’s 510 (k) K840943, Pre-filled Respiratory Therapy Vial, cleared on April 24, 1983. Dey’s Sodium Chloride Inhalation Solution USP 0.9% product is a… | 1984 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113033 | Sodium Chlorde Inhalation Solution, 0.9% Usp-3ML | 2012 | 3 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K142153Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15MLTeleflexmedical, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K113033 (Nephron Pharmaceuticals Corp., 2012) has gone furthest, with 3 descendants of its own.
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?
For respiratory therapy and tracheal 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/K980829 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980829: 3ML Steri-Neb Saline - 0.9% W/V 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/K980829
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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