Cleared Traditional

K921443 - TIP & MEMBRANE ASSEMBLY (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921443 · Bio-Rad · Ophthalmic device
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Jun 1993
Decision
483d
Days
Class 2
Risk

K921443 is an FDA 510(k) clearance for the TIP & MEMBRANE ASSEMBLY. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Bio-Rad (Glendale, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 483 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

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Submission Details

510(k) Number K921443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1992
Decision Date June 22, 1993
Days to Decision 483 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
373d slower than avg
Panel avg: 110d · This submission: 483d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
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.