510(k) · Cleared
ClearedMedrad High Pressure Conecting Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · DWE Tubing, Pump, Cardiopulmonary Bypass
Cleared on Apr 17, 1981 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 17, 1981
- Review
- 11 days
- Class
- Class II
- Product code
- DWE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK810924 Medrad High Pressure Conecting TubeMedrad, Inc. · 1981
- Descendant · cites it directly · 2 of its ownK071196 Disposable High Pressure Injection Lines with and Without Rotating…Coeur, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK140356 Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK131770 Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK131517 Medrad Twist & GO High Pressure Connector TubingMedrad, Inc. / Bayer Medical Care, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K071196Disposable High Pressure Injection Lines with and Without Rotating AdaptersCoeur, Inc. · 2007 · cites it directly2descendants
- K140356Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015 · 2 generations on0descendants
- K131770Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2014 · 2 generations on0descendants
- K131517Medrad Twist & GO High Pressure Connector TubingMedrad, Inc. / Bayer Medical Care, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810924 | Medrad High Pressure Conecting Tube | Medrad, Inc. | 1981 | — |
| +1 | K071196 | Disposable High Pressure Injection Lines with and Without Rotating Adapters | Coeur, Inc. | 2007 | — |
| +2 | K140356 | Summed High Pressure Line | Sunny Medical Device (Shenzhen) Co., Ltd. | 2015 | — |
| +2 | K131770 | Pressure Connecting Tube | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2014 | — |
| +1 | K131517 | Medrad Twist & GO High Pressure Connector Tubing | Medrad, Inc. / Bayer Medical Care, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071196 (Coeur, Inc., 2007) has gone furthest, with 2 descendants 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/K810924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K810924: Medrad High Pressure Conecting Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810924
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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