Cleared Traditional

K853635 - SUBDERM TM

K853635 is an FDA 510(k) clearance for SUBDERM TM, manufactured by General Medical Co.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K853635 · General Medical Co. · Physical Medicine device
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Dec 1985
Decision
112d
Days
Class 2
Risk

K853635 is an FDA 510(k) clearance for the SUBDERM TM. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by General Medical Co. (Washington, US). The FDA issued a Cleared decision on December 20, 1985 after a review of 112 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 General Medical Co. devices

FDA 510(k) Submission Details - K853635

510(k) Number K853635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1985
Decision Date December 20, 1985
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
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 K853635.
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