Cleared Traditional

K791527 - RESPIRATOR DISCONNECT ALARM CR201

K791527 is the FDA 510(k) clearance for RESPIRATOR DISCONNECT ALARM CR201 by Intersect Medical Products, Inc.. It is a Class 2 Anesthesiology device (product code CAP) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K791527 · Intersect Medical Products, Inc. · Anesthesiology device
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Sep 1979
Decision
40d
Days
Class 2
Risk

K791527 is an FDA 510(k) clearance for the RESPIRATOR DISCONNECT ALARM CR201. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Intersect Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 19, 1979 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intersect Medical Products, Inc. devices

Submission Details

510(k) Number K791527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date September 19, 1979
Days to Decision 40 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 140d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
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 Anesthesiology devices follow this clearance model.