Cleared Traditional

STERILE AMBULATORY RESERVOIR 60ML/100ML (K962159) - FDA 510(k) Clearance

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

K962159 · Faulding Medical Device Co. · General Hospital
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Jul 1997
Decision
409d
Days
Class 2
Risk

K962159 is an FDA 510(k) clearance for the STERILE AMBULATORY RESERVOIR 60ML/100ML. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Faulding Medical Device Co. (Scottsdale, US). The FDA issued a Cleared decision on July 18, 1997 after a review of 409 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Faulding Medical Device Co. devices

Submission Details

510(k) Number K962159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1996
Decision Date July 18, 1997
Days to Decision 409 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
280d slower than avg
Panel avg: 129d · This submission: 409d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRZ Accessories, Pump, Infusion
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.