Cleared Traditional

K800087 - ULTRASONIC FLOWMETER

K800087 is an FDA 510(k) clearance for ULTRASONIC FLOWMETER, manufactured by The Perkin-Elmer Corp.. The device is a Class 1 Anesthesiology device with product code BXP cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K800087 · The Perkin-Elmer Corp. · Anesthesiology device
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Mar 1980
Decision
65d
Days
Class 1
Risk

K800087 is an FDA 510(k) clearance for the ULTRASONIC FLOWMETER. Classified as Transducer, Gas Flow (product code BXP), Class I - General Controls.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1980 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2885 - 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 The Perkin-Elmer Corp. devices

FDA 510(k) Submission Details - K800087

510(k) Number K800087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1980
Decision Date March 19, 1980
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

BXP Device Classification - Class 1, General Controls

Product Code BXP Transducer, Gas Flow
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2885
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.