Cleared Traditional

K770581 - CORRUGATED TUBING, 770 & 771

K770581 is an FDA 510(k) clearance for CORRUGATED TUBING, manufactured by C.D. & F. Corp.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K770581 · C.D. & F. Corp. · Anesthesiology device
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Apr 1977
Decision
22d
Days
Class 1
Risk

K770581 is an FDA 510(k) clearance for the CORRUGATED TUBING, 770 & 771. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by C.D. & F. Corp. (Walker, US). The FDA issued a Cleared decision on April 19, 1977 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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.

FDA 510(k) Submission Details - K770581

510(k) Number K770581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1977
Decision Date April 19, 1977
Days to Decision 22 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 140d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
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 - BZO Set, Tubing And Support, Ventilator (w Harness)

All 61
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K770581.
PIGGYBACK BREATHING CIRCUIT
K791034 · Vital Signs, Inc. · Jun 1979
RAIN-X
K791060 · Sherwood Medical Co. · Jun 1979
VOL. VENTILATOR SETUP W/OUT NEBULIZER
K772069 · Inspiron Corp. · Nov 1977
CORRUGATED TUBING #770 & 771
K770593 · Surgicot, Inc. · Apr 1977
MECK/MILLER VENTILATION TUBE HARNESS
K760993 · Timeter Instrument Corp. · Dec 1976
K770581 · CORRUGATED TUBING, 770 & 771
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