510(k) · Cleared
Recalled · Class II · 2018Duo Flow Catheter-MC 54
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · KNZ Accessories, A-V Shunt
Cleared on Jul 26, 1984 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 11 times.
- Decided
- Jul 26, 1984
- Review
- 36 days
- Class
- Class II
- Product code
- KNZ
- Recalls
- 11
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNZ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2018 | Class II | Z-2937-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
| Jul 12, 2018 | Class II | Z-2942-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
| Jul 12, 2018 | Class II | Z-2935-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
| Jul 12, 2018 | Class II | Z-2934-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
| Jul 12, 2018 | Class II | Z-2936-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
| Jul 12, 2018 | Class II | Z-2938-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
| Jul 12, 2018 | Class II | Z-2941-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
| Jul 12, 2018 | Class II | Z-2940-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
| Jul 12, 2018 | Class II | Z-2939-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
| Jul 12, 2018 | Class II | Z-2933-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
| Jul 12, 2018 | Class II | Z-2932-2018 | Process control | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KNZ devicesKNZ Accessories, A-V Shunt: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNZ
FDA has decided no KNZ device since 2007.
Median 510(k) review, days · KNZ
Too few KNZ 510(k)s in any year since 2007 to give a median.
Recalls per year · KNZ
No recall names KNZ since 2007.
Adverse event reports per year · KNZ
2in 2021
MAUDE reports naming product code KNZ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K842416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K842416: Duo Flow Catheter-MC 54.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K842416
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026