Cleared Traditional

K904726 - LYTENING TM 6/R

K904726 is an FDA 510(k) clearance for LYTENING TM 6/R, manufactured by Amdev, Inc.. The device is a Class 2 Chemistry device with product code JFP cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K904726 · Amdev, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
62d
Days
Class 2
Risk

K904726 is an FDA 510(k) clearance for the LYTENING TM 6/R. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by Amdev, Inc. (Danvers, US). The FDA issued a Cleared decision on December 18, 1990 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Amdev, Inc. devices

FDA 510(k) Submission Details - K904726

510(k) Number K904726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1990
Decision Date December 18, 1990
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFP Device Classification - Class 2, Special Controls

Product Code JFP Electrode, Ion Specific, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - JFP Electrode, Ion Specific, Calcium

All 19
Devices cleared under the same product code (JFP) and FDA review panel - the closest regulatory comparables to K904726.
EASY LYTE CALCIUM ANALYZER
K943091 · Medica Corp. · Jan 1995
AVL 988-4 ELECTROLYTE ANALYZER
K943702 · Avl Scientific Corp. · Sep 1994
ELECTRODE, ION SPECIFIC
K915675 · Alko Diagnostic Corp. · Apr 1992
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY
K884771 · Instrumentation Laboratory CO · Feb 1989
CORNING CALCIUM PH ANALYZER 634
K844188 · Corning Medical & Scientific · Feb 1985
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM
K830213 · Nova Biomedical Corp. · Apr 1983