510(k) · Cleared
ClearedHyper Sal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pari Innovative Manufacturers, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Apr 26, 2007 as substantially equivalent to K972778 (Dey Laboratories, Inc., 1997) after a 65-day review. Its family tree reaches back 2 generations to 1984. 5 later devices descend from it.
- Decided
- Apr 26, 2007
- Review
- 65 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K841988 (1984). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK841988 Arm-a-Vial LV Sodium, Chloride InhalatArmour Pharmaceutical Co. · 1984
- 1 generation backK972778 Dey Vial Sodium Chloride 3%Dey Laboratories, Inc. · 1997
- This deviceK070498 Hyper SalPari Innovative Manufacturers, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK101424 Pharmacaribe Inhaled Saline SolutionsPharmacaribe · 2010
- Descendant · 2 generations on · 0 of its ownK232523 Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited · 2024
- Descendant · 2 generations on · 0 of its ownK210126 Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation · 2021
- Descendant · 2 generations on · 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 5 of 5 · See all- K101424Pharmacaribe Inhaled Saline SolutionsPharmacaribe · 2010 · cites it directly4descendants
- K232523Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited · 2024 · 2 generations on0descendants
- K210126Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation · 2021 · 2 generations on0descendants
- K130091PulmosalPharmacaribe · 2013 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −2 | K841988 | Arm-a-Vial LV Sodium, Chloride Inhalat | Armour Pharmaceutical Co. | 1984 | — |
| −1 | K972778 | Dey Vial Sodium Chloride 3% | Dey Laboratories, Inc. | 1997 | — |
| 0 (this device) | K070498 | Hyper Sal | Pari Innovative Manufacturers, Inc. | 2007 | — |
| +1 | K101424 | Pharmacaribe Inhaled Saline Solutions | Pharmacaribe | 2010 | — |
| +2 | K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | 2024 | — |
| +2 | K210126 | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% | The Ritedose Corporation | 2021 | — |
| +2 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K972778 | Dey Vial Sodium Chloride 3%Summary page 1…ulizer (Direct Patient Interface) Device: Inhaled saline solutions - 3.5%, 6% and 7% Predicate Devices: DEY Laboratories - K972778 IDevice Description: The proposed inhaled saline solutions are in 3.5%, 6% and 7% concentrations. They are packaged sterile in… | 1997 |
What descends from it? (5)
2 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 23 years and passes through 3 companies; a new generation was cleared every 13.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K101424 (Pharmacaribe, 2010) has gone furthest, with 4 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. 2007, 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?
Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070498: Hyper Sal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070498
Report an extraction error
Are you the manufacturer?
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