Cleared Traditional

K884834 - XOMED IONESTHETIZER(TM)

K884834 is the FDA 510(k) clearance for XOMED IONESTHETIZER(TM) by Xomed, Inc.. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K884834 · Xomed, Inc. · Physical Medicine device
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Feb 1989
Decision
89d
Days
Class 2
Risk

K884834 is an FDA 510(k) clearance for the XOMED IONESTHETIZER(TM). Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 15, 1989 after a review of 89 days - a notably fast clearance cycle.

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: 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 Xomed, Inc. devices

Submission Details

510(k) Number K884834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received November 18, 1988
Decision Date February 15, 1989
Days to Decision 89 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K884834.
IONTOPHORESIS DEVICE
K903093 · Empi · Oct 1990
TBD IONTOPHORESIS ELECTRODE
K896703 · Empi · Feb 1990
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
K894549 · Henley Intl. · Feb 1990
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