510(k) · Cleared
Recalled · Class II · 2015Express Chest Drain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrium Medical Corp. · KDQ Bottle, Collection, Vacuum
Cleared on Jul 25, 2008 after a 37-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 4 times.
- Decided
- Jul 25, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- KDQ
- Recalls
- 4
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KDQ? 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’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| May 7, 2015 | Class II | Z-1938-2015 | Process control | Chest drains have a missing o-ring |
| May 7, 2015 | Class II | Z-1936-2015 | Process control | Chest drains have a missing o-ring |
| May 7, 2015 | Class II | Z-1937-2015 | Process control | Chest drains have a missing o-ring |
| May 7, 2015 | Class II | Z-1935-2015 | Process control | Chest drains have a missing o-ring |
No ancestor or descendant has a Class I recall.
How does its category compare?
All KDQ devicesKDQ Bottle, Collection, Vacuum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KDQ
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · KDQ
Too few KDQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KDQ
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KDQ
49in 2025
MAUDE reports naming product code KDQ, 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 | 48 |
| 2008 | 1 | — | 0 | 67 |
| 2009 | 0 | — | 2 | 165 |
| 2010 | 0 | — | 1 | 50 |
| 2011 | 0 | — | 0 | 40 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 2 | 43 |
| 2015 | 0 | — | 1 (1) | 34 |
| 2016 | 0 | — | 1 | 77 |
| 2017 | 0 | — | 0 | 53 |
| 2018 | 0 | — | 0 | 45 |
| 2019 | 0 | — | 1 | 57 |
| 2020 | 0 | — | 0 | 110 |
| 2021 | 0 | — | 1 | 110 |
| 2022 | 0 | — | 1 | 118 |
| 2023 | 0 | — | 1 | 92 |
| 2024 | 0 | — | 0 | 164 |
| 2025 | 0 | — | 0 | 49 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To evacuate air and/or fluid from the chest cavity or mediastinum.
To help re-establish lung expansion and restore breathing dynamics.
To facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081718: Express Chest Drain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081718
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026