Cleared Traditional

INFUSA PU SYRINGE INFUSION PUMP (K904924) - FDA 510(k) Clearance

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

K904924 · Ferguson Medical · General Hospital
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Sep 1991
Decision
314d
Days
Class 2
Risk

K904924 is an FDA 510(k) clearance for the INFUSA PU SYRINGE INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 314 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Ferguson Medical devices

Submission Details

510(k) Number K904924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1990
Decision Date September 10, 1991
Days to Decision 314 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
185d slower than avg
Panel avg: 129d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 221
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K904924.
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · Abbott Laboratories · Oct 1991
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K913720 · Abbott Laboratories · Oct 1991
FLO-GARD(R) 6200, 6300 & 8000
K913895 · Baxter Healthcare Corp · Oct 1991
LIFECARE 4100 PCA INFUSER PLUS II
K912928 · Abbott Laboratories · Aug 1991
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
K911964 · Abbott Laboratories · Aug 1991
MODIFIED LIFECARE MODEL 175 INFUSER
K912092 · Abbott Laboratories · Aug 1991