# K043582: Ocean Chest Drain

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: Jan 21, 2005 after 24 days
- Product code: KDQ (Bottle, Collection, Vacuum)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has 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
- K103042: Atmos E 201 Thorax and Atmos S 201 Thorax (2011), 1 descendant of its own
- K241799: ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C (2025), 0 descendants 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

## Recalls of this device
- Sep 5, 2023 · Class II · Z-0486-2024: 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.
- Oct 18, 2022 · Class II · Z-0235-2023: Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
- May 25, 2022 · Class II · Z-1607-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Oct 22, 2021 · Class II · Z-0307-2022: Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
- Dec 23, 2016 · Class II · Z-1210-2017: 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-1209-2017: 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-1206-2017: 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-1205-2017: 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

## 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/K043582
Methodology: https://510kreport.com/methodology