Cleared Traditional

K881477 - HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED (FDA 510(k) Clearance)

Class I Pathology device.

K881477 · Stat Path · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
11d
Days
Class 1
Risk

K881477 is an FDA 510(k) clearance for the HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED. Classified as Adhesive, Albumin-based (product code KEL), Class I - General Controls.

Submitted by Stat Path (Riderwood, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - the FDA pathology 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 Stat Path devices

Submission Details

510(k) Number K881477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1988
Decision Date April 18, 1988
Days to Decision 11 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 77d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KEL Adhesive, Albumin-based
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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.