510(k) · Cleared
Recalled · 2010Adapter, Catheter Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · KGZ Accessories, Catheter
Cleared on Dec 12, 1978 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 3 times.
- Decided
- Dec 12, 1978
- Review
- 41 days
- Class
- Class I
- Product code
- KGZ
- Recalls
- 3
- 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 KGZ? 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 |
|---|---|---|---|---|
| Jun 7, 2010 | Not classified | Z-2274-2010 | Process change control | Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed. |
| Dec 15, 2009 | Not classified | Z-1538-2010 | Packaging | Some central venous catheter sets had the incorrect lid stock. |
| Feb 11, 2009 | Not classified | Z-1493-2009 | Device Design | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All KGZ devicesKGZ Accessories, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGZ
FDA has decided no KGZ device since 2007.
Median 510(k) review, days · KGZ
Too few KGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · KGZ
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGZ
30in 2025
MAUDE reports naming product code KGZ, 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 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 4 | 7 |
| 2010 | 0 | — | 2 | 37 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 54 |
| 2017 | 0 | — | 0 | 78 |
| 2018 | 0 | — | 0 | 100 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 0 | — | 1 | 113 |
| 2021 | 0 | — | 0 | 36 |
| 2022 | 0 | — | 0 | 88 |
| 2023 | 0 | — | 0 | 55 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 3 | 30 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K781846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K781846: Adapter, Catheter Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781846
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026