510(k) · Cleared
Recalled · Class II · 2021Atrium Medical Corporation Express 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 May 5, 1999 after a 139-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 5, 1999
- Review
- 139 days
- Class
- Class II
- Product code
- KDQ
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK984496 Atrium Medical Corporation Express Chest DrainAtrium Medical Corp. · 1999
- Descendant · cites it directly · 0 of its ownK062302 Millicore AB Digivent Chest Drainage SystemMillicore AB · 2006
Most influential descendants
Showing 1 of 1 · See all- K062302Millicore AB Digivent Chest Drainage SystemMillicore AB · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984496 | Atrium Medical Corporation Express Chest Drain | Atrium Medical Corp. | 1999 | — |
| +1 | K062302 | Millicore AB Digivent Chest Drainage System | Millicore AB | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062302 | Millicore AB Digivent Chest Drainage System | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2021 | Class II | Z-2592-2021 | Under Investigation by firm | The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died. |
| Dec 23, 2016 | Class II | Z-1208-2017 | Process control | Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062302 (Millicore AB, 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KDQ devicesKDQ Bottle, Collection, Vacuum: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 collection of autologous blood from the patient’s pleural cavity or mediastinal area for reinfusion purposes in post-operative and trauma blood loss management.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984496: Atrium Medical Corporation 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/K984496
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026