Cleared Traditional

K770374 - STYLETTE, SLICK, CAT. NO. 2000B (FDA 510(k) Clearance)

Class I Anesthesiology device.

K770374 · Medical Products Div. P.O.L.A. Plasti · Anesthesiology device
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Mar 1977
Decision
33d
Days
Class 1
Risk

K770374 is an FDA 510(k) clearance for the STYLETTE, SLICK, CAT. NO. 2000B. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Medical Products Div. P.O.L.A. Plasti (Mchenry, US). The FDA issued a Cleared decision on March 30, 1977 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5790 - 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 Medical Products Div. P.O.L.A. Plasti devices

Submission Details

510(k) Number K770374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1977
Decision Date March 30, 1977
Days to Decision 33 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 139d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSR Stylet, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5790
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.