Cleared Traditional

K780649 - FLAME PHOTOMETER

K780649 is the FDA 510(k) clearance for FLAME PHOTOMETER by Corning Medical & Scientific. It is a Class 1 Chemistry device (product code JJO) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K780649 · Corning Medical & Scientific · Chemistry device
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May 1978
Decision
37d
Days
Class 1
Risk

K780649 is an FDA 510(k) clearance for the FLAME PHOTOMETER, MODEL 435. Classified as Flame Emission Photometer For Clinical Use (product code JJO), Class I - General Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2540 - 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K780649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1978
Decision Date May 26, 1978
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJO Flame Emission Photometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2540
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 - JJO Flame Emission Photometer For Clinical Use

All 11
Devices cleared under the same product code (JJO) and FDA review panel - the closest regulatory comparables to K780649.
SHABAN #9868 TUBING KIT-9870 STYLET
K832937 · Shaban Mfg. Co. · Oct 1983
IL 943 FLAME PHOTOMETER
K823480 · Instrumentation Laboratory CO · Jan 1983
CORNING 480 FLAME PHOTOMETER
K820631 · Corning Medical & Scientific · Apr 1982
FLAME PHOTOMETER, MODEL 455
K780650 · Corning Medical & Scientific · May 1978
I.L. MODEL 643 FLAME PHOTOMETER
K771337 · Instrumentation Laboratory CO · Oct 1977