Cleared Traditional

K820157 - XOMED THERMAL MYRINGOTOMY SYSTEM

K820157 is the FDA 510(k) clearance for XOMED THERMAL MYRINGOTOMY SYSTEM by Xomed, Inc.. It is a Class 2 Ophthalmic device (product code HQP) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K820157 · Xomed, Inc. · Ophthalmic device
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Mar 1982
Decision
42d
Days
Class 2
Risk

K820157 is an FDA 510(k) clearance for the XOMED THERMAL MYRINGOTOMY SYSTEM. Classified as Unit, Cautery, Thermal, Battery-powered (product code HQP), Class II - Special Controls.

Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on March 2, 1982 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - the FDA ophthalmic 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 K820157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1982
Decision Date March 02, 1982
Days to Decision 42 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 110d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQP Unit, Cautery, Thermal, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - HQP Unit, Cautery, Thermal, Battery-powered

All 9
Devices cleared under the same product code (HQP) and FDA review panel - the closest regulatory comparables to K820157.
OPTHERM EXTRA FINE TIP
K840426 · Suncoast Medical Manufacturers, Inc. · May 1984
REPLACE-A-TIP RECHARG. LOW TEMP.
K841325 · Suncoast Medical Manufacturers, Inc. · May 1984
REPLACE-A-TIP RECHARGEABLE HIGH TEMP
K841326 · Suncoast Medical Manufacturers, Inc. · May 1984
HOT TEMP CAUTERY
K771189 · Edward Weck, Inc. · Jul 1977