Cleared Traditional

K811419 - SPRIO-LOOP

K811419 is the FDA 510(k) clearance for SPRIO-LOOP by Datamed, Inc.. It is a Class 1 General & Plastic Surgery device (product code BTX) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K811419 · Datamed, Inc. · General & Plastic Surgery device
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Jun 1981
Decision
24d
Days
Class 1
Risk

K811419 is an FDA 510(k) clearance for the SPRIO-LOOP. Classified as Board, Arm (with Cover), Sterile (product code BTX), Class I - General Controls.

Submitted by Datamed, Inc. (Walker, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3910 - 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 Datamed, Inc. devices

Submission Details

510(k) Number K811419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1981
Decision Date June 12, 1981
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BTX Board, Arm (with Cover), Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3910
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.