Cleared Traditional

K884978 - PHARMA-PLAST INSULIN INFUSION SET (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884978 · Pharma-Plast USA, Inc. · General Hospital
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Jun 1989
Decision
203d
Days
Class 2
Risk

K884978 is an FDA 510(k) clearance for the PHARMA-PLAST INSULIN INFUSION SET. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Pharma-Plast USA, Inc. (Canada H3a 2n4, CA). The FDA issued a Cleared decision on June 21, 1989 after a review of 203 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharma-Plast USA, Inc. devices

Submission Details

510(k) Number K884978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1988
Decision Date June 21, 1989
Days to Decision 203 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
75d slower than avg
Panel avg: 128d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZG Pump, Infusion, Insulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LZG Pump, Infusion, Insulin

All 83
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