Cleared Traditional

K860352 - SPACELABS AIRWAY ADAPTER SET SERIES

K860352 is an FDA 510(k) clearance for SPACELABS AIRWAY ADAPTER SET SERIES, manufactured by Spacelabs, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K860352 · Spacelabs, Inc. · Anesthesiology device
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Mar 1986
Decision
48d
Days
Class 1
Risk

K860352 is an FDA 510(k) clearance for the SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Spacelabs, Inc. (Chatsworth, US). The FDA issued a Cleared decision on March 19, 1986 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 Spacelabs, Inc. devices

FDA 510(k) Submission Details - K860352

510(k) Number K860352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1986
Decision Date March 19, 1986
Days to Decision 48 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
92d faster than avg
Panel avg: 140d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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 - BZA Connector, Airway (extension)

All 35
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K860352.
BRITISH BREATHING CIRCUIT SYSTEM
K860878 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
DISPOSABLE CATHETER
K860882 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
STRAIGHT CONNECTORS, 15MM, 30MM & 19MM
K860885 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
CATHETER MOUNTS & ELBOWS (VARIOUS TYPES)
K860881 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
STRAIGHT CONNECTORS, 22MM
K860886 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
T-PIECES CONNECTORS
K860887 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986