510(k) · Cleared
Recalled · Class II · 2017Pressure Display Box #60000/Tubing Set #61000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dlp, Inc. · DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Cleared on Aug 9, 1985 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Aug 9, 1985
- Review
- 79 days
- Class
- Class II
- Product code
- DXS
- Recalls
- 4
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK852232 Pressure Display Box #60000/Tubing Set #61000Dlp, Inc. · 1985
- Descendant · cites it directly · 0 of its ownK113235 Pressure Display Box,DLP Disposable Pressure Display Sets-Non…Medtronic, Inc. · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K113235Pressure Display Box,DLP Disposable Pressure Display Sets-Non Sterile VersionsMedtronic, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K852232 | Pressure Display Box #60000/Tubing Set #61000 | Dlp, Inc. | 1985 | — |
| +1 | K113235 | Pressure Display Box,DLP Disposable Pressure Display Sets-Non Sterile Versions | Medtronic, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113235 | Pressure Display Box,DLP Disposable Pressure Display Sets-Non Sterile Versions | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2017 | Class II | Z-2768-2017 | Packaging process control | Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. |
| Sep 9, 2011 | Not classified | Z-0078-2012 | Device Design | Pressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). Use beyond 6 hours may result in air… |
| Sep 9, 2011 | Not classified | Z-0077-2012 | Device Design | The DFU for the Medtronic Pressure Display Box, model 66000, states that, for display readings of -100 to +300 mmHg there will be an accuracy of +/-5 mmHg, and for display readings of +301 to +500 mmHg there will be an accuracy of +/-10… |
| Sep 9, 2011 | Not classified | Z-0079-2012 | Device Design | Pressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). Use beyond 6 hours may result in air… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113235 (Medtronic, Inc., 2011) has gone furthest, with 0 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K852232 · printed Nov 4, 2026
Cite this page
510(k) Report. “K852232: Pressure Display Box #60000/Tubing Set #61000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852232
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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