Cleared Traditional

K792268 - CIRCAPAK

K792268 is the FDA 510(k) clearance for CIRCAPAK by Respiratory Care, Inc.. It is a Class 1 Anesthesiology device (product code BZO) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K792268 · Respiratory Care, Inc. · Anesthesiology device
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Nov 1979
Decision
18d
Days
Class 1
Risk

K792268 is an FDA 510(k) clearance for the CIRCAPAK. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Respiratory Care, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1979 after a review of 18 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.

View all Respiratory Care, Inc. devices

Submission Details

510(k) Number K792268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1979
Decision Date November 27, 1979
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 13
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K792268.
INSPIRON NEONATAL VENTILATOR CIRCUIT
K821064 · C.R. Bard, Inc. · May 1982
3M VOLUME VENTIATOR CIRCUIT
K820131 · 3M Company · Jan 1982
PEDIATRIC VENTILATOR CIRCUIT 2C7131
K813155 · Travenol Laboratories, S.A. · Dec 1981
TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT
K792030 · Airlife, Inc. · Oct 1979
CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT,
K792047 · Airlife, Inc. · Oct 1979
CIRCUIT, BREATHING W/WO NEBULIZER
K791761 · Airlife, Inc. · Oct 1979