Cleared Traditional

K781908 - BREATHING CIRCUIT PRODUCTS

K781908 is an FDA 510(k) clearance for BREATHING CIRCUIT PRODUCTS, manufactured by Hospitak, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K781908 · Hospitak, Inc. · Anesthesiology device
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Nov 1978
Decision
13d
Days
Class 1
Risk

K781908 is an FDA 510(k) clearance for the BREATHING CIRCUIT PRODUCTS, ANESTHESIA. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Hospitak, Inc. (Walker, US). The FDA issued a Cleared decision on November 27, 1978 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 Hospitak, Inc. devices

FDA 510(k) Submission Details - K781908

510(k) Number K781908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1978
Decision Date November 27, 1978
Days to Decision 13 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
127d faster than avg
Panel avg: 140d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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 - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 48
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K781908.
ADULT ANESTHESIA BREATHING CIRCUITS . .
K800498 · Airlife, Inc. · Mar 1980
PEDIATRIC ANESTHESIA BREATHING CIRCUITS
K800499 · Airlife, Inc. · Mar 1980
MODIFIED JACKSON-REES CIRCUIT
K790214 · Vital Signs, Inc. · Mar 1979
BREATHING CIRCUIT, BAIN
K780044 · Respiratory Care, Inc. · Feb 1978
HI-MID CURCUIT
K771034 · Draeger Medical, Inc. · Aug 1977
BAIN BREATHING CIRCUIT
K771307 · Respiratory Care, Inc. · Aug 1977