Cleared Traditional

K905703 - KRUPIN EYE VALVE WITH DISK

K905703 is an FDA 510(k) clearance for KRUPIN EYE VALVE WITH DISK, manufactured by Hood Laboratories. The device is a Class 2 Ophthalmic device with product code KYF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K905703 · Hood Laboratories · Ophthalmic device
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Mar 1991
Decision
85d
Days
Class 2
Risk

K905703 is an FDA 510(k) clearance for the KRUPIN EYE VALVE WITH DISK. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 15, 1991 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3920 - 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 Hood Laboratories devices

FDA 510(k) Submission Details - K905703

510(k) Number K905703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1990
Decision Date March 15, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYF Device Classification - Class 2, Special Controls

Product Code KYF Implant, Eye Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3920
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 - KYF Implant, Eye Valve

All 7
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K905703.
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K885125 · Hood Laboratories · Jan 1989
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K875099 · Staar Surgical Co. · Mar 1988