Cleared Traditional

THAYER METERED DOSE INHALER DISPENSER/ADAPTER (K901739) - FDA 510(k) Clearance

Class I Anesthesiology device.

K901739 · Thayer Medical Corp. · Anesthesiology device
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Oct 1990
Decision
176d
Days
Class 1
Risk

K901739 is an FDA 510(k) clearance for the THAYER METERED DOSE INHALER DISPENSER/ADAPTER. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on October 9, 1990 after a review of 176 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.

View all Thayer Medical Corp. devices

Submission Details

510(k) Number K901739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1990
Decision Date October 09, 1990
Days to Decision 176 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 140d · This submission: 176d
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 14
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K901739.
COAXIAL CIRCUITS
K932587 · Merit Medical Systems, Inc. · Jul 1993
MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS
K925231 · Merit Medical Systems, Inc. · Jan 1993
MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT
K925232 · Merit Medical Systems, Inc. · Jan 1993
BABYFLEX HEATED INFANT BREATHING CIRCUIT
K896365 · Baxter Healthcare Corp · Jan 1990
ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP
K893919 · Baxter Healthcare Corp · Sep 1989
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
K881141 · Baxter Healthcare Corp · Apr 1988