Cleared Traditional

K851797 - 53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K851797 · Artiberia · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
28d
Days
Class 1
Risk

K851797 is an FDA 510(k) clearance for the 53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH. Classified as Speculum, Rectal (product code FFQ), Class I - General Controls.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on May 23, 1985 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - the FDA gastroenterology and urology 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 Artiberia devices

Submission Details

510(k) Number K851797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date May 23, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FFQ Speculum, Rectal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.