Cleared Traditional

K940083 - STANDARD PHACO TIP 15, 30, 45, 60

K940083 is an FDA 510(k) clearance for STANDARD PHACO TIP 15, manufactured by Medical Technical Products. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K940083 · Medical Technical Products · Ophthalmic device
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Sep 1994
Decision
264d
Days
Class 2
Risk

K940083 is an FDA 510(k) clearance for the STANDARD PHACO TIP 15, 30, 45, 60. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Medical Technical Products (Laguna Hills, US). The FDA issued a Cleared decision on September 28, 1994 after a review of 264 days - an extended review 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: 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 Medical Technical Products devices

FDA 510(k) Submission Details - K940083

510(k) Number K940083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1994
Decision Date September 28, 1994
Days to Decision 264 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 110d · This submission: 264d
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 K940083.
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PHACO KIT
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10-0 CASSETTE
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