Cleared Traditional

K882536 - OPHTHALMIC PAO VALVE

K882536 is the FDA 510(k) clearance for OPHTHALMIC PAO VALVE by Look, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K882536 · Look, Inc. · General Hospital
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Sep 1988
Decision
80d
Days
Class 2
Risk

K882536 is an FDA 510(k) clearance for the OPHTHALMIC PAO VALVE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Look, Inc. (Boston, US). The FDA issued a Cleared decision on September 9, 1988 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Look, Inc. devices

Submission Details

510(k) Number K882536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date September 09, 1988
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 294
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