Cleared Traditional

K841294 - ACU220 CRYO UNIT

K841294 is an FDA 510(k) clearance for ACU220 CRYO UNIT, manufactured by Keller Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HQA cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K841294 · Keller Instruments, Inc. · Ophthalmic device
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Aug 1984
Decision
139d
Days
Class 2
Risk

K841294 is an FDA 510(k) clearance for the ACU220 CRYO UNIT. Classified as Unit, Cryotherapy, Ophthalmic (product code HQA), Class II - Special Controls.

Submitted by Keller Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4170 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Keller Instruments, Inc. devices

FDA 510(k) Submission Details - K841294

510(k) Number K841294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1984
Decision Date August 15, 1984
Days to Decision 139 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 110d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQA Device Classification - Class 2, Special Controls

Product Code HQA Unit, Cryotherapy, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4170
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.