510(k) · Cleared
ClearedChest Drainage Tubing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olson Medical Sales, Inc. · DWE Tubing, Pump, Cardiopulmonary Bypass
Cleared on Dec 10, 1999 as substantially equivalent to K870792 (Gish Biomedical, Inc., 1987) after an 88-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Dec 10, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- DWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K870792 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK870792 Thorastat Atr-XXXXGish Biomedical, Inc. · 1987
- This deviceK993062 Chest Drainage TubingOlson Medical Sales, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870792 | Thorastat Atr-XXXX | Gish Biomedical, Inc. | 1987 | — |
| 0 (this device) | K993062 | Chest Drainage Tubing | Olson Medical Sales, Inc. | 1999 | — |
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.
Planning a device in DWE? 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 DWE device
- #1 K233702 SMARxT Tubing and Connectorsscore 7.8 · 1 generation · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K870792 | Thorastat Atr-XXXXSummary page 1…stantially equivalent in intended use, design, technology/principle of operation, materials and performance to the cleared Gish Biomedical Tubing that is cleared through K870792. Principle of Operation/Technology: The chest drainage tubing is used as a conduit for fluids being removed from the body follo… | 1987 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All DWE devicesDWE Tubing, Pump, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWE
Too few DWE 510(k)s in any year since 2007 to give a median.
Recalls per year · DWE
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWE
80in 2025
MAUDE reports naming product code DWE, 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 | — | 2 | 10 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 1 | 17 |
| 2010 | 0 | — | 2 | 20 |
| 2011 | 0 | — | 2 | 9 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 1 | — | 1 | 129 |
| 2015 | 1 | — | 0 | 133 |
| 2016 | 0 | — | 0 | 151 |
| 2017 | 0 | — | 2 | 131 |
| 2018 | 0 | — | 0 | 134 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 45 |
| 2021 | 0 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 123 |
| 2023 | 0 | — | 0 | 286 |
| 2024 | 1 | — | 0 | 221 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Chest Drainage Tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures
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/K993062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993062: Chest Drainage Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993062
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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