510(k) · Cleared
Recalled · Class I · 2023Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrium Medical Corporation · CAC Apparatus, Autotransfusion
Cleared on Sep 3, 2021 as substantially equivalent to K043140 (Atrium Medical Corp., 2004) and 1 other predicate after a 476-day review. Its family tree reaches back 1 generation to 2004. 2 of the 3 devices in its family, counting itself, have a Class I recall. It has been recalled 4 times, including a Class I recall.
- Decided
- Sep 3, 2021
- Review
- 476 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 4 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K043140 (2004). 2 ancestors in all. No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK043140 Express and Oasis Chest DrainAtrium Medical Corp. · 2004 · Recalled (Class I)
- This deviceK201305 Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain…Atrium Medical Corporation · 2021
Class I recalls in this family
- K043140 Express and Oasis Chest Draindirect predicate · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043140 | Express and Oasis Chest Drain | Atrium Medical Corp. | 2004 | Class I |
| 0 (this device) | K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry… | Atrium Medical Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043140 | Express and Oasis Chest DrainSummary page 5…ion Water Seal Chest Drains and Express Dry Seal Chest Drains are substantially equivalent in function and intended use to the Express Chest Drain and Oasis Chest Drain (K043140) and Ocean Water Seal Chest Drain (K043582). Device Description Atrium’s Auto transfusion (ATS) Chest Drains are sterile, sin… | 2004 |
| * | K043582 | Ocean Chest DrainSummary page 5…Seal Chest Drains are substantially equivalent in function and intended use to the Express Chest Drain and Oasis Chest Drain (K043140) and Ocean Water Seal Chest Drain (K043582). Device Description Atrium’s Auto transfusion (ATS) Chest Drains are sterile, single use, disposable devices that mimic a tr… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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-0710-2024 | 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… |
| 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 18, 2023 | Class II | Z-0316-2024 | 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 |
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.
- K043140Express and Oasis Chest DrainAtrium Medical Corp. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K043140.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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?
* Evacuate air and/or fluid from the chest cavity or mediastinum.
* Help re-establish lung expansion and restore breathing dynamics.
Chest Drain Auto transfusion (ATS)
To facilitate collection of autologous blood from the patient’s pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201305 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201305: Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201305
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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