Cleared Traditional

K873311 - DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 (FDA 510(k) Clearance)

Class I General Hospital device.

K873311 · Dale Medical Products, Inc. · General Hospital
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Nov 1987
Decision
80d
Days
Class 1
Risk

K873311 is an FDA 510(k) clearance for the DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on November 5, 1987 after a review of 80 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 Dale Medical Products, Inc. devices

Submission Details

510(k) Number K873311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1987
Decision Date November 05, 1987
Days to Decision 80 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
48d faster than avg
Panel avg: 128d · This submission: 80d
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.