Cleared Traditional

K801418 - KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT

K801418 is an FDA 510(k) clearance for KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT, manufactured by Keeler Optical Products , Ltd.. The device is a Class 2 Ophthalmic device with product code HPS cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K801418 · Keeler Optical Products , Ltd. · Ophthalmic device
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Jul 1980
Decision
34d
Days
Class 2
Risk

K801418 is an FDA 510(k) clearance for the KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT. Classified as Unit, Cryophthalmic (product code HPS), Class II - Special Controls.

Submitted by Keeler Optical Products , Ltd. (Walker, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 34 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K801418

510(k) Number K801418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1980
Decision Date July 21, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 110d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HPS Device Classification - Class 2, Special Controls

Product Code HPS Unit, Cryophthalmic
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.

Regulatory Peers - HPS Unit, Cryophthalmic

All 9
Devices cleared under the same product code (HPS) and FDA review panel - the closest regulatory comparables to K801418.
KEELER ACU 22XT OPHTHALMIC CRYO UNIT
K874555 · Keeler Instruments, Inc. · Jan 1988
KEELER CTU CRYO SYSTEM
K873388 · Keeler Instruments, Inc. · Nov 1987
UNITED SURGICAL CORP. CRYOPTIC PLUS
K870195 · United Surgical Corp. · Feb 1987
BEAVER CATARACT CYROXTRACTOR
K781338 · Edward Weck, Inc. · Feb 1979
MODEL 556-01 CRYOEXTRACTOR
K790102 · Intermedics, Inc. · Feb 1979
K801418 · KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT
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