Cleared Traditional

K953175 - AS/3 ESTPR MODULE (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953175 · Datex Division Instrumentarium Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
580d
Days
Class 2
Risk

K953175 is an FDA 510(k) clearance for the AS/3 ESTPR MODULE. Classified as Monitor, St Segment With Alarm (product code MLD), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on February 6, 1997 after a review of 580 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Datex Division Instrumentarium Corp. devices

Submission Details

510(k) Number K953175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1995
Decision Date February 06, 1997
Days to Decision 580 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
455d slower than avg
Panel avg: 125d · This submission: 580d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MLD Monitor, St Segment With Alarm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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.