Cleared Traditional

PATIENT GAS SAMPLING LINE FOR OHMEDA 6000 (K910509) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910509 · Intertech Resources, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
71d
Days
Class 2
Risk

K910509 is an FDA 510(k) clearance for the PATIENT GAS SAMPLING LINE FOR OHMEDA 6000. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on April 17, 1991 after a review of 71 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 Intertech Resources, Inc. devices

Submission Details

510(k) Number K910509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1991
Decision Date April 17, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 140d · This submission: 71d
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 61
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K910509.
HP M1465A STANDARD AIRWAY ADAPTER
K933980 · Hewlett-Packard Co. · Sep 1993
MASS SPECTROMETRY MONITORING LINE CONONECTORS
K925167 · Merit Medical Systems, Inc. · Jan 1993
DATASCOPE PASSPORT MONITOR WITH CO2
K921526 · Datascope Corp. · Oct 1992
DATASCOPE MULTINEX ID MONITOR
K910106 · Datascope Corp. · Mar 1991
MODEL AO-800PA CO2 MODULE
K894691 · Nihon Kohden America, Inc. · Dec 1989
HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02
K896030 · Hewlett-Packard Co. · Dec 1989