510(k) · Cleared
ClearedSterile Water for Device Irrigation/ Sterile Saline for Device Irrigation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welcon, Inc. · JOL Catheter And Tip, Suction
Cleared on Feb 5, 1998 as substantially equivalent to K842166 (Intermed, Inc., 1985) after a 128-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Feb 5, 1998
- Review
- 128 days
- Class
- Class II
- Product code
- JOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K842166 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK842166 Intermed, Ins Sterile Water/SalineIntermed, Inc. · 1985
- This deviceK973734 Sterile Water for Device Irrigation/ Sterile Saline for Device…Welcon, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842166 | Intermed, Ins Sterile Water/Saline | Intermed, Inc. | 1985 | — |
| 0 (this device) | K973734 | Sterile Water for Device Irrigation/ Sterile Saline for Device Irrigation | Welcon, Inc. | 1998 | — |
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 |
|---|---|---|---|
| * | K842166 | Intermed, Ins Sterile Water/SalineSummary page 1…rrigation (Catalog #5575) {ntcrmed, Inc. Sparta. New Jerscy 07871 K&842166 Sterile 0.9% Saline for Irrigation (Catalog #5565) Intermed, Inc. Sparta, New Jerscy 07871 K842166 Product Description: . The Welcon Sterile Water and Sterile 0.9% Normal Salinc for Device Irrigation are individual, single-use… | 1985 |
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?
The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.
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/K973734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973734: Sterile Water for Device Irrigation/ Sterile Saline for Device Irrigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973734
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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