Cleared Traditional

K950178 - PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET (FDA 510(k) Clearance)

Class I Orthopedic device.

K950178 · Pharma-Plast Intl. A/S · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
181d
Days
Class 1
Risk

K950178 is an FDA 510(k) clearance for the PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION.... Classified as Isometer (product code LZE), Class I - General Controls.

Submitted by Pharma-Plast Intl. A/S (Londonderry, US). The FDA issued a Cleared decision on July 17, 1995 after a review of 181 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1520 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K950178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date July 17, 1995
Days to Decision 181 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 122d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZE Isometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1520
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.