510(k) · Cleared
Recalled · Class I · 2026Arrow Peritoneal Lavage Catherization K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · GBW Catheter, Peritoneal
Cleared on Aug 10, 1981 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- Aug 10, 1981
- Review
- 62 days
- Class
- Class I
- Product code
- GBW
- Recalls
- 2 (1 Class I)
- 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.
1 device in this family has a Class I recall. 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2380-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
| Aug 2, 2004 | Not classified | Z-1408-04 | Other | wrong introducer needle in some kits |
No ancestor or descendant has a Class I recall.
How does its category compare?
All GBW devicesGBW Catheter, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBW
FDA has decided no GBW device since 2007.
Median 510(k) review, days · GBW
Too few GBW 510(k)s in any year since 2007 to give a median.
Recalls per year · GBW
6in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBW
28in 2023
MAUDE reports naming product code GBW, 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 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 6 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 (1) | — |
https://510kreport.com/device/K811627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K811627: Arrow Peritoneal Lavage Catherization K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811627
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026