Cleared Traditional

K772055 - PENTAX F.O.-IT OBSERVER SCOPE

K772055 · Pilling Co. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1977
Decision
15d
Days
-
Risk

K772055 is an FDA 510(k) clearance for the PENTAX F.O.-IT OBSERVER SCOPE.

Submitted by Pilling Co. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1977 after a review of 15 days - a notably fast clearance cycle.

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: 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 Pilling Co. devices

Submission Details

510(k) Number K772055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1977
Decision Date November 15, 1977
Days to Decision 15 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 110d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -