Cleared Traditional

K990091 - S.P.A.R STERILE AMBULATORY RESERVOIR

K990091 is an FDA 510(k) clearance for S.P.A.R STERILE AMBULATORY RESERVOIR, manufactured by Faulding Pharmaceutical Co.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K990091 · Faulding Pharmaceutical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
83d
Days
Class 2
Risk

K990091 is an FDA 510(k) clearance for the S.P.A.R STERILE AMBULATORY RESERVOIR. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Faulding Pharmaceutical Co. (Cranford, US). The FDA issued a Cleared decision on April 4, 1999 after a review of 83 days - a notably fast clearance 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: 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 Faulding Pharmaceutical Co. devices

FDA 510(k) Submission Details - K990091

510(k) Number K990091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1999
Decision Date April 04, 1999
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MRZ Accessories, Pump, Infusion

All 23
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