510(k) · Cleared
Recalled · Class II · 2015Pulmosal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacaribe · CAF Nebulizer (Direct Patient Interface)
Cleared on Mar 13, 2013 as substantially equivalent to K101424 (Pharmacaribe, 2010) and 1 other predicate after a 57-day review. Its family tree reaches back 4 generations to 1984. It has been recalled once.
- Decided
- Mar 13, 2013
- Review
- 57 days
- Class
- Class II
- Product code
- CAF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K841988 (1984). 12 ancestors in all, the oldest K840943 (1984). No later device cites it as a predicate yet.
- Root · 4 generations backK841988 Arm-a-Vial LV Sodium, Chloride InhalatArmour Pharmaceutical Co. · 1984
- 3 generations backK972778 Dey Vial Sodium Chloride 3%Dey Laboratories, Inc. · 1997
- 2 generations backK070498 Hyper SalPari Innovative Manufacturers, Inc. · 2007
- 1 generation backK101424 Pharmacaribe Inhaled Saline SolutionsPharmacaribe · 2010
- This deviceK130091 PulmosalPharmacaribe · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K841988 | Arm-a-Vial LV Sodium, Chloride Inhalat | Armour Pharmaceutical Co. | 1984 | — |
| −3 | K972778 | Dey Vial Sodium Chloride 3% | Dey Laboratories, Inc. | 1997 | — |
| −2 | K070498 | Hyper Sal | Pari Innovative Manufacturers, Inc. | 2007 | — |
| −1 | K101424 | Pharmacaribe Inhaled Saline Solutions | Pharmacaribe | 2010 | — |
| 0 (this device) | K130091 | Pulmosal | Pharmacaribe | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K101424 | Pharmacaribe Inhaled Saline SolutionsSummary page 1…ns - 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4 Predicate Device: PharmaCaribe - Sodium Inhalation solutions - K 101424 Device Description: The proposed inhaled saline solutions are in 0.9%, 3%, 3.5%, 6%, 7%, and 10% concentrations with a pH of 7.4… | 2010 |
| * | K113033 | Sodium Chlorde Inhalation Solution, 0.9% Usp-3MLSummary page 3…utions 3%, 3.5%, 6%, 7% and 10% 3%, 3.5%, 6%, 7% and 10% 0.9% 0.9% -K 113033 -Nephron Pharma - USP pH PH 7.… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2015 | Class II | Z-0795-2016 | Error in labeling | Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 9.5 years on median.
- None of the 12 ancestors has a recall.
- 3 other devices also cite its predicate K101424.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated.
Concentrations of 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130091 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130091: Pulmosal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130091
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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