Cleared Traditional

K882598 - 250 ML BAG W/Y INJECT. & 12 EXTENSION SET

K882598 is an FDA 510(k) clearance for 250 ML BAG W/Y INJECT. & 12 EXTENSION SET, manufactured by Prn Services, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K882598 · Prn Services, Inc. · General Hospital
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Nov 1988
Decision
130d
Days
Class 2
Risk

K882598 is an FDA 510(k) clearance for the 250 ML BAG W/Y INJECT. & 12 EXTENSION SET. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Prn Services, Inc. (Royal Oak, US). The FDA issued a Cleared decision on November 1, 1988 after a review of 130 days - within the typical 510(k) review window.

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 Prn Services, Inc. devices

FDA 510(k) Submission Details - K882598

510(k) Number K882598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1988
Decision Date November 01, 1988
Days to Decision 130 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
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN 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 - FRN Pump, Infusion

All 612
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K882598.
FLO-GARD VP
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BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
K882556 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988