Cleared Traditional

K945565 - SPIRO-FLEX

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

K945565 · Inhalation Plastics · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K945565

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.

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 117
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K945565.
PRIMA ADULT GAS SAMPLING CIRCUITS
K952019 · Prima, Inc. · May 1995
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
K952020 · Prima, Inc. · May 1995
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K952009 · Prima, Inc. · May 1995
PRIMA, INC. ADULT ANESTHESIA CIRCUIT
K944533 · Prima, Inc. · Nov 1994
KARL STORZ LARYNGOSCOPE ACCESSORIES
K944295 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
PEDIATRIC ANESTHESIA CIRCUITS
K942122 · Mag, Inc. · Jun 1994