510(k) · Cleared
Recalled · Class II · 2018Tygon Tubing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electromedics, Inc. · DWE Tubing, Pump, Cardiopulmonary Bypass
Cleared on Jan 13, 1981 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 13, 1981
- Review
- 15 days
- Class
- Class II
- Product code
- DWE
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K803277 | Tygon Tubing | Electromedics, Inc. | 1981 | — |
| +1 | K964205 | Better-Tubing | Circulatory Technology, Inc. | 1998 | — |
| +1 | K041650 | Micro Prime | Innovx Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 27, 2018 | Class II | Z-0785-2019 | Process control | Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K964205 (Circulatory Technology, Inc., 1998) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K803277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K803277: Tygon Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K803277
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026