Cleared Traditional

K926454 - ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON

K926454 is an FDA 510(k) clearance for ANESTHESIA RESPIRATORY BREATH CIRCUIT P..., manufactured by Medical, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K926454 · Medical, Inc. · Anesthesiology device
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Jun 1993
Decision
180d
Days
Class 1
Risk

K926454 is an FDA 510(k) clearance for the ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 180 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K926454

510(k) Number K926454 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 24, 1992
Decision Date June 22, 1993
Days to Decision 180 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 140d · This submission: 180d
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 131
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K926454.
ADULT GAS SAMPLING CIRCUITS
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K932196 · Life Shield Healthcare Products, Inc. · Jul 1993
CUSTOM ANESTHESIA CIRCUITS
K932197 · Life Shield Healthcare Products, Inc. · Jul 1993
KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT
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BLD-18000 SERIES HEATED BREATHING CIRCUIT
K925543 · Bird Life Design · Apr 1993
XTEND CIRCUITS (TM)
K924627 · Arc Medical, Inc. · Apr 1993