Cleared Traditional

K971616 - BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)

K971616 is an FDA 510(k) clearance for BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70), manufactured by Data Sciences Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 551-day FDA review.

K971616 · Data Sciences Intl., Inc. · Cardiovascular device
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Nov 1998
Decision
551d
Days
Class 2
Risk

K971616 is an FDA 510(k) clearance for the BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70). Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Data Sciences Intl., Inc. (St. Paul, US). The FDA issued a Cleared decision on November 4, 1998 after a review of 551 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Data Sciences Intl., Inc. devices

FDA 510(k) Submission Details - K971616

510(k) Number K971616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1997
Decision Date November 04, 1998
Days to Decision 551 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
426d slower than avg
Panel avg: 125d · This submission: 551d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 400
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K971616.
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673 · Cordis Corp. · May 1999
NEUROVASX SUB-MICROINFUSION CATHETER
K984258 · Neuro Vasx, Inc. · Feb 1999
MEDTRONIC ANGIOGRAPHIC CATHETER
K980973 · Medtronics Interventional Vascular · Dec 1998
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
K982299 · Daig Corp. · Oct 1998
ENVY GUIDING CATHETER
K974774 · Cook, Inc. · Oct 1998
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
K981788 · Scimed Life Systems, Inc. · Aug 1998