510(k) · Cleared
ClearedContinuous Flush Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · KRA Catheter, Continuous Flush
Cleared on Apr 15, 1997 as substantially equivalent to K873168 (Spectramed, Inc., 1988) and 1 other predicate after a 316-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Apr 15, 1997
- Review
- 316 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 deviceK962129 Continuous Flush DeviceMerit Medical Systems, Inc. · 1997
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) | K962129 | Continuous Flush Device | Merit Medical Systems, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 |
|---|---|---|---|
| * | K873168 | Spectramed Disposable Transducer (DT-Xxo) & AccessSummary page 1…al Care Division Edwards Critical Care Division 1900 Williams Bivd 17221 Red Hill Avenue FAx 801-253-1651 Oxnard, CA 93030 Irvine, CA 92714 (800) 235-5945 (800) 424-3278 K873168 K792141 INDICATIONS FOR USE A continuous flush device is an accessory to a catheter-transducer system that permits a continuous… | 1988 |
| * | K792141 | Continuous Flush DeviceSummary page 1…Division Edwards Critical Care Division 1900 Williams Bivd 17221 Red Hill Avenue FAx 801-253-1651 Oxnard, CA 93030 Irvine, CA 92714 (800) 235-5945 (800) 424-3278 K873168 K792141 INDICATIONS FOR USE A continuous flush device is an accessory to a catheter-transducer system that permits a continuous flow to… | 1979 |
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.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
A continuous flush device is an accessory to a catheter-transducer system that permits a continuous flow to maintain catheter patency.
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/K962129 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962129: Continuous Flush Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962129
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026