510(k) · Cleared
ClearedSterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · JOL Catheter And Tip, Suction
Cleared on Aug 12, 2005 after a 78-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 12, 2005
- Review
- 78 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? (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 |
|---|---|---|---|
| * | — | Baxter Sterile Saline for Catheter Care Named without a submission number | |
| * | — | Welcon Sterile Water for Device Irrigation 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?
Baxter Sterile Water for Device Care and Sterile Saline for Device Care are indicated for irrigation and flushing of medical devices.
Baxter Sterile Water for Device Care and Sterile Saline for Device Care are not indicated for intravascular injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051370: Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051370
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)
- Page last updated Nov 3, 2026