Cleared Traditional

K850508 - LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES

K850508 is an FDA 510(k) clearance for LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA ..., manufactured by Kal Life Systems. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K850508 · Kal Life Systems · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
96d
Days
Class 2
Risk

K850508 is an FDA 510(k) clearance for the LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Kal Life Systems (Mission Viejo, US). The FDA issued a Cleared decision on May 15, 1985 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Kal Life Systems devices

FDA 510(k) Submission Details - K850508

510(k) Number K850508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date May 15, 1985
Days to Decision 96 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGJ Device Classification - Class 2, Special Controls

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - EGJ Device, Iontophoresis, Other Uses

All 58
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K850508.
MEDITRODE KIT
K882554 · Life-Tech Intl., Inc. · Dec 1988
MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
K871869 · Life-Tech Intl., Inc. · Aug 1987
MODEL 6110 IONTOPHORETIC APPLICATOR
K863166 · Life-Tech Intl., Inc. · Mar 1987
IONTOPHORESIS SYSTEM MODULE, DM 500
K770717 · Sorensen Research · Aug 1977
DESENSITRON
K771130 · Parker Laboratories, Inc. · Jul 1977