Cleared Traditional

K803069 - SHELL KRATON THERMO-PLASTIC RUBBER COMP.

K803069 is an FDA 510(k) clearance for SHELL KRATON THERMO-PLASTIC RUBBER COMP., manufactured by Warren E. Collins, Inc.. The device is a Class 1 Anesthesiology device with product code BYP cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K803069 · Warren E. Collins, Inc. · Anesthesiology device
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Dec 1980
Decision
17d
Days
Class 1
Risk

K803069 is an FDA 510(k) clearance for the SHELL KRATON THERMO-PLASTIC RUBBER COMP.. Classified as Mouthpiece, Breathing (product code BYP), Class I - General Controls.

Submitted by Warren E. Collins, Inc. (Walker, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5620 - 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 Warren E. Collins, Inc. devices

FDA 510(k) Submission Details - K803069

510(k) Number K803069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1980
Decision Date December 22, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

BYP Device Classification - Class 1, General Controls

Product Code BYP Mouthpiece, Breathing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5620
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.

Regulatory Peers - BYP Mouthpiece, Breathing

All 17
Devices cleared under the same product code (BYP) and FDA review panel - the closest regulatory comparables to K803069.
MONAGHAN AEROCHAMBER
K822437 · Monaghan Medical Corp. · Nov 1982
DISPOSABLE THERMOPLASTIC RUBBER MOUTH
K821128 · Airlife, Inc. · May 1982
MOUTHPIECE, BREATHING
K810793 · Dhd Medical Products Div. Diemolding Corp. · May 1981
DISPOSABLE MOUTHPIECE
K791537 · Hospitak, Inc. · Sep 1979
CORRUGATED TUBE WITH MOUTHPIECE
K790931 · Mem Medical, Inc. · May 1979
AEROSOL MOUTHPIECE NO. M-091
K790932 · Mem Medical, Inc. · May 1979