# K043140: Express and Oasis Chest Drain

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: Dec 8, 2004 after 23 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 23 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130210: Medela Thopaz (2013), 2 descendants of its own
- K141553: Medela Thopaz+ (2014), 1 descendant of its own
- K201305: Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain (2021), 0 descendants of its own
- K181667: Thoraguard System (2018), 0 descendants of its own

## Recalls of this device
- Dec 13, 2023 · Class I · Z-0709-2024: 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
- Nov 1, 2023 · Class II · Z-0621-2024: 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 
- 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 5, 2023 · Class II · Z-0485-2024: 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: 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: 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: 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: Chest drains have a missing o-ring
- May 7, 2015 · Class II · Z-1936-2015: Chest drains have a missing o-ring
- May 7, 2015 · Class II · Z-1937-2015: Chest drains have a missing o-ring
- May 7, 2015 · Class II · Z-1935-2015: Chest drains have a missing o-ring
- Apr 28, 2014 · Class II · Z-1959-2014: 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: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Nov 19, 2013 · Class II · Z-0736-2014: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Nov 19, 2013 · Class II · Z-0743-2014: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Nov 19, 2013 · Class II · Z-0738-2014: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Nov 19, 2013 · Class II · Z-0737-2014: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Nov 19, 2013 · Class II · Z-0741-2014: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Nov 19, 2013 · Class II · Z-0739-2014: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Nov 19, 2013 · Class II · Z-0740-2014: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Nov 19, 2013 · Class II · Z-0742-2014: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Nov 8, 2006 · Not classified · Z-0500-2007: Chest drainage tubing incorrectly assembled and may disconnect from patient during use

## Indications for use
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.

Source page: https://510kreport.com/device/K043140
Methodology: https://510kreport.com/methodology