510(k) · Cleared
ClearedSodium Chlorde Inhalation Solution, 0.9% Usp-3ML
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nephron Pharmaceuticals Corp. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 19, 2012 as substantially equivalent to K972466 (Holopack International, LP, 1997) and 1 other predicate after a 251-day review. Its family tree reaches back 2 generations to 1987. 1 of the 9 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jun 19, 2012
- Review
- 251 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K870332 (1987). 5 ancestors in all, the oldest K840943 (1984). 3 later devices descend from it, 2 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK870332 Prefilled Respiratory Therapy VialsAutomatic Liquid Packaging, Inc. · 1987
- 1 generation backK972466 Sodium Chloride Inhalation Solution, UspHolopack International, LP · 1997
- This deviceK113033 Sodium Chlorde Inhalation Solution, 0.9% Usp-3MLNephron Pharmaceuticals Corp. · 2012
- Descendant · cites it directly · 1 of its ownK142153 Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution…Teleflexmedical, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK231058 Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP · 2024
- Descendant · cites it directly · 0 of its ownK130091 PulmosalPharmacaribe · 2013 · Recalled
Class I recalls in this family
- K142153 Hudson Rci Addipak Unit Dose Vial, 0.9% Full…cites it directly · 2015
Most influential descendants
Showing 3 of 3 · See all- K142153Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15MLTeleflexmedical, Inc. · 2015 · cites it directly1descendant
- K231058Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP · 2024 · 2 generations on0descendants
- K130091PulmosalPharmacaribe · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870332 | Prefilled Respiratory Therapy Vials | Automatic Liquid Packaging, Inc. | 1987 | — |
| −1 | K972466 | Sodium Chloride Inhalation Solution, Usp | Holopack International, LP | 1997 | — |
| 0 (this device) | K113033 | Sodium Chlorde Inhalation Solution, 0.9% Usp-3ML | Nephron Pharmaceuticals Corp. | 2012 | — |
| +1 | K142153 | Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution… | Teleflexmedical, Inc. | 2015 | Class I |
| +2 | K231058 | Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP | 2024 | — |
| +1 | K130091 | Pulmosal | Pharmacaribe | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K972466 | Sodium Chloride Inhalation Solution, UspSummary page 1…CAF - 868.5630 Class II Device: Inhaled saline solution - 0.9% Predicated Devices: Holopack - K972466 Steripak - K980829 VOL 005 - File 001 - Page 1… | 1997 |
| * | K980829 | 3ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution UspSummary page 1…Class II Device: Inhaled saline solution - 0.9% Predicated Devices: Holopack - K972466 Steripak - K980829 VOL 005 - File 001 - Page 1 nephron Spharmaceuticals c… | 1998 |
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? (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 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K142153 (Teleflexmedical, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K972466.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
This sterile, single-use device is intended to be used as an accessory to medicinal non-ventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.
This device is not intended for parenteral use or for preparations intended for parenteral use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113033: Sodium Chlorde Inhalation Solution, 0.9% Usp-3ML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113033
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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