Cleared Traditional

K945860 - SPECTRUM CO-OXIMETER LINEARITY CONTROL

K945860 is an FDA 510(k) clearance for SPECTRUM CO-OXIMETER LINEARITY CONTROL, manufactured by Phoenix Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K945860 · Phoenix Diagnostics, Inc. · Chemistry device
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Jan 1995
Decision
47d
Days
Class 1
Risk

K945860 is an FDA 510(k) clearance for the SPECTRUM CO-OXIMETER LINEARITY CONTROL. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Phoenix Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on January 17, 1995 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Phoenix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K945860

510(k) Number K945860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1994
Decision Date January 17, 1995
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

JJS Device Classification - Class 1, General Controls

Product Code JJS Controls For Blood-gases, (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJS Controls For Blood-gases, (assayed And Unassayed)

All 57
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K945860.
STAT PROFILE ULTRA BLOOD GAS CONTROLS
K952477 · Nova Biomedical Corp. · Jul 1995
ALKO TONOMETERED SALINE CONTROL
K950902 · Alko Diagnostic Corp. · Mar 1995
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
K946224 · Ciba Corning Diagnostics Corp. · Jan 1995
MULTICHECK(TM)
K935515 · Radiometer America, Inc. · Apr 1994
MICROBACT SOLID PLATE SYSTEMS
K923342 · Radiometer America, Inc. · Sep 1992
BLOOD GAS/ISE LINEARITY CONTROL
K920285 · Phoenix Diagnostics, Inc. · Jul 1992