# K971616: Blood Pressure Measurement System (DSPM-70)

- Pathway: 510(k) (Traditional)
- Applicant: Data Sciences Intl., Inc.
- Decided: Nov 4, 1998 after 551 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mikro-Tip Catheter Pressure Transducer, Millar Instruments, Inc.: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K971616
Methodology: https://510kreport.com/methodology