510(k) · Cleared
ClearedBlood Pressure Measurement System (DSPM-70)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Data Sciences Intl., Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Nov 4, 1998 after a 551-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 4, 1998
- Review
- 551 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | Mikro-Tip Catheter Pressure Transducer, Millar Instruments, Inc. 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The DSPM-70 Blood Pressure Measurement System is suitable for measurement of real-time blood pressure data wherever indwelling blood pressure catheters and transducers are currently used for management of intra-operative and post-surgical critically ill patients. The information measured is suitable for use in derivation of blood pressure parameters such as heart rate, systolic pressure, diastolic pressure, and mean pressure, Not to be used where there…
Read the full statement (407 words)
The DSPM-70 Blood Pressure Measurement System is suitable for measurement of real-time blood pressure data wherever indwelling blood pressure catheters and transducers are currently used for management of intra-operative and post-surgical critically ill patients. The information measured is suitable for use in derivation of blood pressure parameters such as heart rate, systolic pressure, diastolic pressure, and mean pressure,
Not to be used where there is the potential for accidental entry of the catheter into the heart or other site in the body where patient safety may be compromised.
The transmitter portion of the product is intended to be secured to the skin with tape with the distal tip of the pressure sensing catheter placed in the vasculature at a physician specified site.
The system is intended to be limited to use in a single patient for less than 7 days. The external equipment may be reused.
While the DSPM-70 is indicated for 7 days use, research has shown that in some patient populations, risk of infection increases when indwelling catheters remain in use for longer than 72 hours. Duration of use should be determined by institutional guidelines and consideration of various sources of risk to the patient.
The DSPM-70 has no feature that provides the ability to draw blood from the patient.
Intended for use on critically ill intra-operative and post-surgical patients at sites suitable for insertion of a 4 French intravascular catheter under intensive nursing and physician care. Use an introducer sheath with an inside diameter of 0.061 inches such as the Terumo Medical model SR-OX1451CA 14 Ga x 2 inch Surflo I.V. Catheter. Introducer sheath should remain in place after insertion.
Not intended for neonatal use,
Intended for use on critically ill intra-operative and post-surgical patients at sites suitable for insertion of a 2 French intravascular catheter under intensive nursing and physician care. Use an introducer sheath with an inside diameter of 0.034 inches such as the Terumo Medical model SR-OX1832CA 18 Ga x 1 Y inch Surflo I.V. Catheter. Introducer sheath should remain in place after insertion.
Neonatal applications are limited to femoral artery use only.
Warning: Do not insert beyond mark on the catheter to prevent accidental entry of the catheter into organs where entry of the catheter into the organ may compromise patient safety.
Notice: This system includes about 0.2 seconds of time delay in the electronics which may be a factor when compared to an instantaneous device with no time delay.
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/K971616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971616: Blood Pressure Measurement System (DSPM-70).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971616
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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