Cleared Traditional

K922590 - BIO-PEN SRK II CALCULATOR (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K922590 · Bio-Rad · Ophthalmic device
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Aug 1993
Decision
427d
Days
Class 3
Risk

K922590 is an FDA 510(k) clearance for the BIO-PEN SRK II CALCULATOR. Classified as Medical Computers And Software For Ophthalmic Use (product code LQB), Class III - Premarket Approval.

Submitted by Bio-Rad (Glendale, US). The FDA issued a Cleared decision on August 3, 1993 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel. 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. High regulatory complexity 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 K922590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date August 03, 1993
Days to Decision 427 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
317d slower than avg
Panel avg: 110d · This submission: 427d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQB Medical Computers And Software For Ophthalmic Use
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.