Cleared Traditional

K941156 - TECHNISON AXON SYSTEM

K941156 is an FDA 510(k) clearance for TECHNISON AXON SYSTEM, manufactured by Miles, Inc.. The device is a Class 2 Chemistry device with product code KHS cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K941156 · Miles, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
47d
Days
Class 2
Risk

K941156 is an FDA 510(k) clearance for the TECHNISON AXON SYSTEM. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Miles, Inc. (Tarrytown, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - the FDA in vitro diagnostics and chemistry 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 Miles, Inc. devices

FDA 510(k) Submission Details - K941156

510(k) Number K941156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1994
Decision Date April 26, 1994
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHS Device Classification - Class 2, Special Controls

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 Chemistry devices follow this clearance model.

Regulatory Peers - KHS Enzymatic, Carbon-dioxide

All 84
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K941156.
CARBON DIOXIDE - DST
K952410 · Trace America, Inc. · Oct 1995
CARBON DIOXIDE (C02)
K942735 · Teco Diagnostics · Mar 1995
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · Boehringer Mannheim Corp. · Dec 1994
ENZYMATIC CO2 REAGENT, MODIFICATION
K932267 · Intersect Systems, Inc. · Sep 1993
BICARBONATE
K931887 · Em Diagnostic Systems, Inc. · Aug 1993
SYNERMED ENZYMATIC CO2 REAGENT KIT
K924428 · Synermed, Inc. · Dec 1992