510(k) · Cleared
ClearedHydrox Saline Solution 0.9% Sodium Chloride 4 OZ. Cup 120 ML 100 ML Bottle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrox Laboratories · JOL Catheter And Tip, Suction
Cleared on Mar 9, 1998 as substantially equivalent to K943834 (Orion Life Systems, Inc., 1994) after an 80-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Mar 9, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- JOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943834 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK943834 Sterile .9% Sodium Chloride SolutionOrion Life Systems, Inc. · 1994
- This deviceK974759 Hydrox Saline Solution 0.9% Sodium Chloride 4 OZ. Cup 120 ML 100 ML…Hydrox Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943834 | Sterile .9% Sodium Chloride Solution | Orion Life Systems, Inc. | 1994 | — |
| 0 (this device) | K974759 | Hydrox Saline Solution 0.9% Sodium Chloride 4 OZ. Cup 120 ML 100 ML Bottle | Hydrox Laboratories | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K943834 | Sterile .9% Sodium Chloride SolutionSummary page 3…beled as such. The intended use of this device is the same as the intended use of similar devices currently in the market. Refer to Orion 0.9% Sodium Chloride Solution K943834 and Kit Pak Sterile 0.9% Sodium Chloride Solution (number unknown). (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER P… | 1994 |
| * | — | Kit Pak Sterile 0.9% Sodium Chloride Solution Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All JOL devicesJOL Catheter And Tip, Suction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOL
FDA has decided no JOL device since 2007.
Median 510(k) review, days · JOL
Too few JOL 510(k)s in any year since 2007 to give a median.
Recalls per year · JOL
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · JOL
277in 2025
MAUDE reports naming product code JOL, 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 | 0 | — | 0 | 17 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 25 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 0 | — | 1 | 25 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 0 | — | 0 | 42 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 0 | — | 0 | 61 |
| 2017 | 0 | — | 0 | 181 |
| 2018 | 0 | — | 0 | 161 |
| 2019 | 0 | — | 3 | 442 |
| 2020 | 0 | — | 0 | 187 |
| 2021 | 0 | — | 0 | 283 |
| 2022 | 0 | — | 0 | 221 |
| 2023 | 0 | — | 1 (1) | 197 |
| 2024 | 0 | — | 0 | 277 |
| 2025 | 0 | — | 0 | 277 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Not for injection, for suction catheter procedures. Hydrox Sterile Saline 0.9% Sodium Chloride Solution is intended to be used in device lubrication, moistening and flushing. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
The intended use of this device is the same as the intended use of similar devices currently in the market. Refer to Orion 0.9% Sodium Chloride Solution K943834 and Kit Pak Sterile 0.9% Sodium Chloride Solution (number unknown).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974759: Hydrox Saline Solution 0.9% Sodium Chloride 4 OZ. Cup 120 ML 100 ML Bottle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974759
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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