510(k) · Cleared
ClearedArgon Continuous Flush Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Medical Devices, Inc. · KRA Catheter, Continuous Flush
Cleared on Mar 29, 2007 as substantially equivalent to K792141 (Pharmaseal Div., Baxter Healthcare Corp., 1979) and 1 other predicate after a 48-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Mar 29, 2007
- Review
- 48 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K792141 (1979). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK792141 Continuous Flush DevicePharmaseal Div., Baxter Healthcare Corp. · 1979
- This deviceK070384 Argon Continuous Flush DeviceArgon Medical Devices, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792141 | Continuous Flush Device | Pharmaseal Div., Baxter Healthcare Corp. | 1979 | — |
| 0 (this device) | K070384 | Argon Continuous Flush Device | Argon Medical Devices, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 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 KRA? 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K792141 | Continuous Flush DeviceSummary page 1…ansducer including a continuous flush device are the predicate devices for the Argon Continuous Flush Device. The 510(k) for the original Edwards Uniflow Flush Device is K792141, filed by the Edwards Critical Care Division of Baxter Healthcare. K832907 was filed by American Pharmaseal, also a Baxter Edward… | 1979 |
| * | K832907 | Invasive Monitoring KitsSummary page 1…the Argon Continuous Flush Device. The 510(k) for the original Edwards Uniflow Flush Device is K792141, filed by the Edwards Critical Care Division of Baxter Healthcare. K832907 was filed by American Pharmaseal, also a Baxter Edwards company, for a blood pressure transducer that included a continuous flush… | 1984 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K792141.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
For use in invasive physiological pressure measurements which require continuous regulated flow to maintain catheter patency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070384: Argon Continuous Flush Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070384
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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