Cleared Traditional

K850747 - TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR

K850747 is the FDA 510(k) clearance for TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR by Tri-Med, Inc.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K850747 · Tri-Med, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
36d
Days
Class 2
Risk

K850747 is an FDA 510(k) clearance for the TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Tri-Med, Inc. (Redmond, US). The FDA issued a Cleared decision on April 2, 1985 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Tri-Med, Inc. devices

Submission Details

510(k) Number K850747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1985
Decision Date April 02, 1985
Days to Decision 36 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
104d faster than avg
Panel avg: 140d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 147
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K850747.
SERIES 7000 END TIDAL CO2 MONITORING SYSTEM
K851001 · Marquette Electronics, Inc. · May 1985
TRI-MED MODEL 112 MOISTURE TRAP
K850745 · Tri-Med, Inc. · Apr 1985
TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI
K850746 · Tri-Med, Inc. · Apr 1985
CPNOGARD CAPNOMETER 1250
K844010 · Novametrix Medical Systems, Inc. · Feb 1985
TRI-MED 610 CAPNOSTAT GAS ANALYZER
K843285 · Tri-Med, Inc. · Nov 1984
MODEL IM1074 END-TIDAL CO2 MODULE
K843970 · Gould, Inc. · Oct 1984