510(k) · Cleared
Recalled · Class II · 2023Ocean Chest Drain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrium Medical Corp. · KDQ Bottle, Collection, Vacuum
Cleared on Jan 21, 2005 after a 24-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 22 times.
- Decided
- Jan 21, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- KDQ
- Recalls
- 22
- Predicates
- 0
3 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK043582 Ocean Chest DrainAtrium Medical Corp. · 2005
- Descendant · cites it directly · 1 of its ownK103042 Atmos E 201 Thorax and Atmos S 201 ThoraxAtmos, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK241799 ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml…Atmos Medizintechnik GmbH & Co. KG · 2025
- 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)
Class I recalls in this family
- K201305 Auto transfusion (ATS) Chest Drains: Ocean Water…cites it directly · 2021
Most influential descendants
Showing 3 of 3 · See all- K103042Atmos E 201 Thorax and Atmos S 201 ThoraxAtmos, Inc. · 2011 · cites it directly1descendant
- K241799ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system…Atmos Medizintechnik GmbH & Co. KG · 2025 · 2 generations on0descendants
- K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…Atrium Medical Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043582 | Ocean Chest Drain | Atrium Medical Corp. | 2005 | — |
| +1 | K103042 | Atmos E 201 Thorax and Atmos S 201 Thorax | Atmos, Inc. | 2011 | — |
| +2 | K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose… | Atmos Medizintechnik GmbH & Co. KG | 2025 | — |
| +1 | K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry… | Atrium Medical Corporation | 2021 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2021 | 1 | 1 |
| 2025 | 1 | 0 |
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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2023 | Class II | Z-0486-2024 | 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. |
| Oct 18, 2022 | Class II | Z-0235-2023 | Storage | 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 | Environmental control | 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 | Labeling design | 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 | 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-1209-2017 | 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-1206-2017 | 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-1205-2017 | 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 |
The 5 latest of 22 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, K103042 (Atmos, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KDQ devicesKDQ Bottle, Collection, Vacuum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDQ
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · KDQ
Too few KDQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KDQ
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KDQ
49in 2025
MAUDE reports naming product code KDQ, 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 | — | 0 | 48 |
| 2008 | 1 | — | 0 | 67 |
| 2009 | 0 | — | 2 | 165 |
| 2010 | 0 | — | 1 | 50 |
| 2011 | 0 | — | 0 | 40 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 2 | 43 |
| 2015 | 0 | — | 1 (1) | 34 |
| 2016 | 0 | — | 1 | 77 |
| 2017 | 0 | — | 0 | 53 |
| 2018 | 0 | — | 0 | 45 |
| 2019 | 0 | — | 1 | 57 |
| 2020 | 0 | — | 0 | 110 |
| 2021 | 0 | — | 1 | 110 |
| 2022 | 0 | — | 1 | 118 |
| 2023 | 0 | — | 1 | 92 |
| 2024 | 0 | — | 0 | 164 |
| 2025 | 0 | — | 0 | 49 |
| 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/K043582 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043582: Ocean Chest Drain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043582
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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