# K201305: Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corporation
- Decided: Sep 3, 2021 after 476 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K043140 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043140: Express and Oasis Chest Drain, Atrium Medical Corp. (2004) Summary page 5.
- K043582: Ocean Chest Drain, Atrium Medical Corp. (2005) Summary page 5.

## Recalls of this device
- Dec 13, 2023 · Class I · Z-0710-2024: 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. Subsequ
- Sep 18, 2023 · Class II · Z-0317-2024: 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 sin
- Sep 18, 2023 · Class II · Z-0318-2024: 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 sin
- Sep 18, 2023 · Class II · Z-0316-2024: 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 sin

## Indications for use
* 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.

Source page: https://510kreport.com/device/K201305
Methodology: https://510kreport.com/methodology