Cleared Traditional

K853418 - SAFTI-BRACELET (FDA 510(k) Clearance)

Class I General Hospital device.

K853418 · Advanced Biosearch Assn. · General Hospital
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Sep 1985
Decision
37d
Days
Class 1
Risk

K853418 is an FDA 510(k) clearance for the SAFTI-BRACELET. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Advanced Biosearch Assn. (Danville, US). The FDA issued a Cleared decision on September 20, 1985 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - the FDA general hospital 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 Advanced Biosearch Assn. devices

Submission Details

510(k) Number K853418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1985
Decision Date September 20, 1985
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 128d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
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.