Cleared Traditional

K863987 - BI-TEMP TEMPERATURE MONITOR (FDA 510(k) Clearance)

K863987 · Respiratory Support Products, Inc. · Anesthesiology device
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Nov 1986
Decision
35d
Days
-
Risk

K863987 is an FDA 510(k) clearance for the BI-TEMP TEMPERATURE MONITOR.

Submitted by Respiratory Support Products, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on November 18, 1986 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel. 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 Respiratory Support Products, Inc. devices

Submission Details

510(k) Number K863987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1986
Decision Date November 18, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 139d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -