Cleared Traditional

K981907 - V.F.I.-VISCOUS FLUID INFUSION TUBING SET (FDA 510(k) Clearance)

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

K981907 · Peregrine Surgical , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
64d
Days
Class 2
Risk

K981907 is an FDA 510(k) clearance for the V.F.I.-VISCOUS FLUID INFUSION TUBING SET. Classified as Pump, Infusion, Ophthalmic (product code MRH), Class II - Special Controls.

Submitted by Peregrine Surgical , Ltd. (Doylestown, US). The FDA issued a Cleared decision on August 4, 1998 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 880.5725 - 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 Peregrine Surgical , Ltd. devices

Submission Details

510(k) Number K981907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1998
Decision Date August 04, 1998
Days to Decision 64 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
46d faster than avg
Panel avg: 110d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRH Pump, Infusion, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MRH Pump, Infusion, Ophthalmic

All 18
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