510(k) · Cleared
Recalled · Class II · 2023Atrium Thoracic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrium Medical Corp. · GBZ Catheter, Cholangiography
Cleared on Oct 4, 1983 after a 111-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 13 times.
- Decided
- Oct 4, 1983
- Review
- 111 days
- Class
- Class I
- Product code
- GBZ
- Recalls
- 13
- 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 GBZ? 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 |
|---|---|---|---|---|
| Sep 29, 2023 | Class II | Z-0484-2024 | Nonconforming Material/Component | A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date. |
| Oct 12, 2018 | Class II | Z-0560-2019 | Vendor change control | This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious… |
| Jan 20, 2017 | Class II | Z-1222-2017 | Labeling design | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) |
| Jan 20, 2017 | Class II | Z-1221-2017 | Labeling design | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) |
| Oct 26, 2016 | Class II | Z-0577-2017 | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| Oct 26, 2016 | Class II | Z-0576-2017 | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| Oct 26, 2016 | Class II | Z-0578-2017 | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| Oct 26, 2016 | Class II | Z-0579-2017 | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| Oct 26, 2016 | Class II | Z-0580-2017 | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| Oct 26, 2016 | Class II | Z-0582-2017 | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| Oct 26, 2016 | Class II | Z-0583-2017 | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| Oct 26, 2016 | Class II | Z-0581-2017 | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| Jun 19, 2015 | Class II | Z-2346-2015 | Employee error | Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GBZ devicesGBZ Catheter, Cholangiography: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBZ
FDA has decided no GBZ device since 2007.
Median 510(k) review, days · GBZ
Too few GBZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GBZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GBZ
6in 2025
MAUDE reports naming product code GBZ, 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 | 6 |
| 2008 | 0 | — | 7 | 30 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 8 | 8 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 1 | 51 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 1 | 5 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 3 | — |
https://510kreport.com/device/K831931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K831931: Atrium Thoracic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831931
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026