Cleared Traditional

K945565 - SPIRO-FLEX

K945565 is the FDA 510(k) clearance for SPIRO-FLEX by Inhalation Plastics. It is a Class 1 Anesthesiology device (product code CAI) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K945565 · Inhalation Plastics · Anesthesiology device
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Jan 1995
Decision
119d
Days
Class 1
Risk

K945565 is an FDA 510(k) clearance for the SPIRO-FLEX. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Inhalation Plastics (Chicago, US). The FDA issued a Cleared decision on January 13, 1995 after a review of 119 days - within the typical 510(k) review window.

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.

View all Inhalation Plastics devices

Submission Details

510(k) Number K945565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1994
Decision Date January 13, 1995
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 140d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 25
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K945565.
KARL STORZ LARYNGOSCOPE ACCESSORIES
K944295 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
PEDIATRIC GAS SAMPLING CIRCUITS
K932589 · Merit Medical Systems, Inc. · Jul 1993
ADULT GAS SAMPLING CIRCUITS
K932590 · Merit Medical Systems, Inc. · Jul 1993
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K932583 · Merit Medical Systems, Inc. · Jul 1993
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K932588 · Merit Medical Systems, Inc. · Jul 1993
PEDIATRIC ANESTHESIA CIRCUITS
K932585 · Merit Medical Systems, Inc. · Jul 1993