510(k) · Cleared
ClearedPharmacaribe Inhaled Saline Solutions
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 Aug 17, 2010 as substantially equivalent to K972778 (Dey Laboratories, Inc., 1997) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 1984. 4 later devices descend from it.
- Decided
- Aug 17, 2010
- Review
- 89 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K841988 (1984). 5 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK841988 Arm-a-Vial LV Sodium, Chloride InhalatArmour Pharmaceutical Co. · 1984
- 2 generations backK972778 Dey Vial Sodium Chloride 3%Dey Laboratories, Inc. · 1997
- 1 generation backK070498 Hyper SalPari Innovative Manufacturers, Inc. · 2007
- This deviceK101424 Pharmacaribe Inhaled Saline SolutionsPharmacaribe · 2010
- Descendant · cites it directly · 0 of its ownK232523 Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited · 2024
- Descendant · cites it directly · 0 of its ownK210126 Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation · 2021
- Descendant · cites it directly · 0 of its ownK130091 PulmosalPharmacaribe · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK120051 Sodium Chloride Inhalation Solution, 3%, 7%, and 10%, Usp-4MLNephron Pharmaceuticals Corp. · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K232523Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited · 2024 · cites it directly0descendants
- K210126Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation · 2021 · cites it directly0descendants
- K130091PulmosalPharmacaribe · 2013 · cites it directly0descendants
- K120051Sodium Chloride Inhalation Solution, 3%, 7%, and 10%, Usp-4MLNephron Pharmaceuticals Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K841988 | Arm-a-Vial LV Sodium, Chloride Inhalat | Armour Pharmaceutical Co. | 1984 | — |
| −2 | K972778 | Dey Vial Sodium Chloride 3% | Dey Laboratories, Inc. | 1997 | — |
| −1 | K070498 | Hyper Sal | Pari Innovative Manufacturers, Inc. | 2007 | — |
| 0 (this device) | K101424 | Pharmacaribe Inhaled Saline Solutions | Pharmacaribe | 2010 | — |
| +1 | K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | 2024 | — |
| +1 | K210126 | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% | The Ritedose Corporation | 2021 | — |
| +1 | K130091 | Pulmosal | Pharmacaribe | 2013 | 1 |
| +1 | K120051 | Sodium Chloride Inhalation Solution, 3%, 7%, and 10%, Usp-4ML | Nephron Pharmaceuticals Corp. | 2012 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 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.
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 |
|---|---|---|---|
| * | K972778 | Dey Vial Sodium Chloride 3%Summary page 1…CAF - 868.5630 Device: Inhaled saline solutions - 3%, 3.5%, 6%, 7%, and 10% Predicate Devices: DRY Laboratories - K972778 Pari - K070498 Device Description: PharmaCaribe Sodium Chloride Solutions are homogeneous… | 1997 |
| * | K070498 | Hyper SalSummary page 1…Inhaled saline solutions - 3%, 3.5%, 6%, 7%, and 10% Predicate Devices: DRY Laboratories - K972778 Pari - K070498 Device Description: PharmaCaribe Sodium Chloride Solutions are homogeneous mixtures (complete solutions) and are composed ofUlSP… | 2007 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 9.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K232523 (Mankind Pharma Limited, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K972778.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 3%, 3.5%, 6%, 7%, and 10%
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/K101424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101424: Pharmacaribe Inhaled Saline Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101424
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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