Cleared Traditional

K871449 - ONCOLOGY SPT SYS #MS-C10 MEDICATION RES...

K871449 is the FDA 510(k) clearance for ONCOLOGY SPT SYS #MS-C10 MEDICATION RES... by Pa Medical Corp.. It is a Class 2 General Hospital device (product code KPE) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K871449 · Pa Medical Corp. · General Hospital
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Jun 1987
Decision
65d
Days
Class 2
Risk

K871449 is an FDA 510(k) clearance for the ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Pa Medical Corp. (Columbia, US). The FDA issued a Cleared decision on June 17, 1987 after a review of 65 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - 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 Pa Medical Corp. devices

Submission Details

510(k) Number K871449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1987
Decision Date June 17, 1987
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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 - KPE Container, I.v.

All 38
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K871449.
EMPTY VIAFLEX PLASTIC CONTAINER
K922214 · Baxter Healthcare Corp · Mar 1993
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · Abbott Laboratories · Dec 1989
CHURCHILL PARENTERAL NUTRITION BAG - EVA
K870395 · Churchill Corp. · Oct 1987
NUTRIMIX EMPTY CONTAINER
K860042 · Abbott Laboratories · Apr 1986
VIAL DECANTER
K852893 · Advance Medical Designs, Inc. · Sep 1985
BAG DECANTER
K852777 · Advance Medical Designs, Inc. · Aug 1985