510(k) · Cleared
Recalled · Class I · 2023Express and Oasis Chest Drain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrium Medical Corp. · CAC Apparatus, Autotransfusion
Cleared on Dec 8, 2004 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 5 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 23 times, including a Class I recall.
- Decided
- Dec 8, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 23 (1 Class I)
- Predicates
- 0
4 later devices descend from it, 2 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- This deviceK043140 Express and Oasis Chest DrainAtrium Medical Corp. · 2004
- Descendant · cites it directly · 2 of its ownK130210 Medela ThopazMedela AG · 2013
- Descendant · 2 generations on · 1 of its ownK141553 Medela Thopaz+Medela AG · 2014
- Descendant · cites it directly · 0 of its ownK201305 Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain…Atrium Medical Corporation · 2021 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK181667 Thoraguard SystemCentese, Inc. · 2018
Class I recalls in this family
- K201305 Auto transfusion (ATS) Chest Drains: Ocean Water…cites it directly · 2021
Most influential descendants
Showing 4 of 4 · See all- K130210Medela ThopazMedela AG · 2013 · cites it directly2descendants
- K141553Medela Thopaz+Medela AG · 2014 · 2 generations on1descendant
- K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…Atrium Medical Corporation · 2021 · cites it directly0descendants
- K181667Thoraguard SystemCentese, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043140 | Express and Oasis Chest Drain | Atrium Medical Corp. | 2004 | — |
| +1 | K130210 | Medela Thopaz | Medela AG | 2013 | — |
| +2 | K141553 | Medela Thopaz+ | Medela AG | 2014 | — |
| +1 | K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry… | Atrium Medical Corporation | 2021 | Class I |
| +3 | K181667 | Thoraguard System | Centese, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 1 |
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.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAC device
- #1 K240426 Aventus Clot Management Systemscore 11.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2023 | Class I | Z-0709-2024 | Material/Component Contamination | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not… |
| Nov 1, 2023 | Class II | Z-0621-2024 | Nonconforming Material/Component | A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients… |
| Sep 18, 2023 | Class II | Z-0317-2024 | Error in labeling | Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains |
| Sep 18, 2023 | Class II | Z-0318-2024 | Error in labeling | Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains |
| Sep 5, 2023 | Class II | Z-0485-2024 | Labeling mix-ups | Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation. |
| Dec 23, 2016 | Class II | Z-1207-2017 | Process control | Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. |
| Dec 23, 2016 | Class II | Z-1211-2017 | Process control | Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. |
| 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. |
| 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 |
| Apr 28, 2014 | Class II | Z-1959-2014 | Nonconforming Material/Component | Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error. |
| Nov 19, 2013 | Class II | Z-0735-2014 | Device Design | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect |
| Nov 19, 2013 | Class II | Z-0736-2014 | Device Design | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect |
| Nov 19, 2013 | Class II | Z-0743-2014 | Device Design | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect |
| Nov 19, 2013 | Class II | Z-0738-2014 | Device Design | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect |
| Nov 19, 2013 | Class II | Z-0737-2014 | Device Design | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect |
| Nov 19, 2013 | Class II | Z-0741-2014 | Device Design | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect |
| Nov 19, 2013 | Class II | Z-0739-2014 | Device Design | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect |
| Nov 19, 2013 | Class II | Z-0740-2014 | Device Design | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect |
| Nov 19, 2013 | Class II | Z-0742-2014 | Device Design | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect |
| Nov 8, 2006 | Not classified | Z-0500-2007 | Other | Chest drainage tubing incorrectly assembled and may disconnect from patient during use |
The 5 latest of 23 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain…Atrium Medical Corporation · 2021 · Cites it directly · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K130210 (Medela AG, 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAC
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAC
91in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAC
7in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CAC
128in 2025
MAUDE reports naming product code CAC, 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 | 35 |
| 2008 | 1 | — | 5 | 12 |
| 2009 | 0 | — | 25 | 68 |
| 2010 | 4 | 123 | 3 | 115 |
| 2011 | 2 | — | 3 | 939 |
| 2012 | 3 | 90 | 0 | 249 |
| 2013 | 1 | — | 9 | 153 |
| 2014 | 3 | 269 | 0 | 90 |
| 2015 | 0 | — | 0 | 87 |
| 2016 | 2 | — | 0 | 73 |
| 2017 | 1 | — | 2 | 88 |
| 2018 | 2 | — | 2 | 87 |
| 2019 | 1 | — | 23 | 64 |
| 2020 | 1 | — | 0 | 108 |
| 2021 | 4 | 155 | 0 | 73 |
| 2022 | 1 | — | 0 | 65 |
| 2023 | 2 | — | 7 (2) | 39 |
| 2024 | 3 | 91 | 0 | 129 |
| 2025 | 0 | — | 0 | 128 |
| 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 as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043140: Express and Oasis 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/K043140
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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