510(k) · Cleared
ClearedSterile Water and 0.9% Sodium Chloride for Irrigation, Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Automatic Liquid Packaging, Inc. · JOL Catheter And Tip, Suction
Cleared on Oct 25, 2000 after a 308-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 25, 2000
- Review
- 308 days
- Class
- Class II
- Product code
- JOL
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 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? (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 |
|---|---|---|---|
| * | — | Sterile Water and Saline Solutions 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.
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?
Sterile Water and Saline Solutions are defined
as an accessory to a device that is intended
For Device Cleaning and Irrigation.
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/K994321 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994321: Sterile Water and 0.9% Sodium Chloride for Irrigation, Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994321
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026