510(k) · Cleared
Recalled · Class II · 2024Pressure Display Box,DLP Disposable Pressure Display Sets-Non Sterile Versions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Cleared on Dec 2, 2011 as substantially equivalent to K852232 (Dlp, Inc., 1985) after a 30-day review. Its family tree reaches back 1 generation to 1985. It has been recalled once.
- Decided
- Dec 2, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- DXS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K852232 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK852232 Pressure Display Box #60000/Tubing Set #61000Dlp, Inc. · 1985 · Recalled
- This deviceK113235 Pressure Display Box,DLP Disposable Pressure Display Sets-Non…Medtronic, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852232 | Pressure Display Box #60000/Tubing Set #61000 | Dlp, Inc. | 1985 | 4 |
| 0 (this device) | K113235 | Pressure Display Box,DLP Disposable Pressure Display Sets-Non Sterile Versions | Medtronic, Inc. | 2011 | — |
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 DXS? 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? (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 |
|---|---|---|---|
| * | K852232 | Pressure Display Box #60000/Tubing Set #61000Summary page 1…Box: 21 CFR 870.43 10 Product Code: DXS Classification: Class 11 Predicate Device Pressure Display Box and Pressure Tubing Set (K852232 - Cleared August 09, 1985) Comparison to Predicate Device A comparison of the modified device and the currently marketed Pressu… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2024 | Class II | Z-1802-2024 | Process control | Potential for unsealed sterile packing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All DXS devicesDXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DXS
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · DXS
Too few DXS 510(k)s in any year since 2007 to give a median.
Recalls per year · DXS
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXS
No MAUDE report names DXS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 3 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery.
This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113235: Pressure Display Box,DLP Disposable Pressure Display Sets-Non Sterile Versions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113235
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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