Cleared Traditional

K841325 - REPLACE-A-TIP RECHARG. LOW TEMP.

K841325 is an FDA 510(k) clearance for REPLACE-A-TIP RECHARG. LOW TEMP., manufactured by Suncoast Medical Manufacturers, Inc.. The device is a Class 2 Ophthalmic device with product code HQP cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K841325 · Suncoast Medical Manufacturers, Inc. · Ophthalmic device
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May 1984
Decision
37d
Days
Class 2
Risk

K841325 is an FDA 510(k) clearance for the REPLACE-A-TIP RECHARG. LOW TEMP.. Classified as Unit, Cautery, Thermal, Battery-powered (product code HQP), Class II - Special Controls.

Submitted by Suncoast Medical Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 37 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 Suncoast Medical Manufacturers, Inc. devices

FDA 510(k) Submission Details - K841325

510(k) Number K841325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date May 09, 1984
Days to Decision 37 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
73d faster than avg
Panel avg: 110d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQP Device Classification - Class 2, Special Controls

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 K841325.
OPHTHALMIC CAUTERY
K945493 · Aaron Medical Industries · Jan 1995
OPTHERM FINE TIP
K840425 · Suncoast Medical Manufacturers, Inc. · May 1984
OPTHERM EXTRA FINE TIP
K840426 · Suncoast Medical Manufacturers, Inc. · May 1984
REPLACE-A-TIP RECHARGEABLE HIGH TEMP
K841326 · Suncoast Medical Manufacturers, Inc. · May 1984
XOMED THERMAL MYRINGOTOMY SYSTEM
K820157 · Xomed, Inc. · Mar 1982
HOT TEMP CAUTERY
K771189 · Edward Weck, Inc. · Jul 1977