510(k) · Cleared
Recalled · 2006Invasive Blood Pressure (Ibp) Function, Model 9500 Multigas Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magnetic Resonance Equipment Corp. · DSK Computer, Blood-Pressure
Cleared on Dec 12, 1999 after a 452-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Dec 12, 1999
- Review
- 452 days
- Class
- Class II
- Product code
- DSK
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DSK? 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 DSK device
- #1 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · 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 |
|---|---|---|---|
| * | — | BCI Model 9100 Multigas Monitor with Invasive Blood Pressure function Named without a submission number |
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 |
|---|---|---|---|---|
| Sep 29, 2006 | Not classified | Z-0258-2007 | Other | Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DSK devicesDSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSK
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DSK
Too few DSK 510(k)s in any year since 2007 to give a median.
Recalls per year · DSK
No recall names DSK since 2007.
Adverse event reports per year · DSK
26in 2025
MAUDE reports naming product code DSK, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 93 |
| 2019 | 0 | — | 0 | 148 |
| 2020 | 0 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 31 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Invasive blood pressure function is an option for the Model 9500 Multigas monitor. This function would be used when a clinician determined the need for continuous monitoring of arterial or venous blood pressure for adult patients undergoing MRI examination.
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/K983250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983250: Invasive Blood Pressure (Ibp) Function, Model 9500 Multigas Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983250
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026