Cleared Traditional

K881359 - DECALCIFYING SOLUTION II (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K881359 · Stephens Scientific · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
19d
Days
Class 1
Risk

K881359 is an FDA 510(k) clearance for the DECALCIFYING SOLUTION II. Classified as Solvent, Adhesive Tape (product code KOX), Class I - General Controls.

Submitted by Stephens Scientific (Denville, US). The FDA issued a Cleared decision on April 19, 1988 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4730 - the FDA general and plastic surgery 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 Stephens Scientific devices

Submission Details

510(k) Number K881359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1988
Decision Date April 19, 1988
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 114d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOX Solvent, Adhesive Tape
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4730
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.