Cleared Traditional

K854116 - PHACO PACKS, 1A PACKS & PACK COMPONENTS

K854116 is an FDA 510(k) clearance for PHACO PACKS, manufactured by Medical Corp. of America. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K854116 · Medical Corp. of America · Ophthalmic device
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Dec 1985
Decision
80d
Days
Class 2
Risk

K854116 is an FDA 510(k) clearance for the PHACO PACKS, 1A PACKS & PACK COMPONENTS. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Medical Corp. of America (Laguna Niguel, US). The FDA issued a Cleared decision on December 27, 1985 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 Medical Corp. of America devices

FDA 510(k) Submission Details - K854116

510(k) Number K854116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1985
Decision Date December 27, 1985
Days to Decision 80 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 110d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 198
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K854116.
OPHTHALMIC FITLER MICRO CAPSULE
K863729 · Ipax, Inc. · Oct 1986
US PLUS-PAK(R) SURGICAL SYSTEM
K863209 · Ipax, Inc. · Sep 1986
SITE PHACO DISPOSABLE CASSETTE
K861060 · Site Microsurgical Systems, Inc. · May 1986
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
K854375 · CooperVision, Inc. · Dec 1985
O.M.S. ULTRA-PHACO
K844373 · Optical Micro Systems, Inc. · Dec 1985
PHACO-BAC STOP FILTER KIT
K852208 · Staar Surgical Co. · Aug 1985