Cleared Traditional

K904924 - INFUSA PU SYRINGE INFUSION PUMP

K904924 is an FDA 510(k) clearance for INFUSA PU SYRINGE INFUSION PUMP, manufactured by Ferguson Medical. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 314-day FDA review.

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

FDA 510(k) Submission Details - K904924

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
Combination Product No
PCCP Authorized No
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.

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 604
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K904924.
FLO-GARD(R) 6200, 6300 & 8000
K913895 · Baxter Healthcare Corp · Oct 1991
AVI MODEL 840D DUAL CHANNEL INFUSION PUMP
K912589 · 3M Avi, Inc. · Oct 1991
AVI MODEL 400D INFUSION PUMP
K912590 · 3M Avi, Inc. · Oct 1991
INFUSA T SYRINGE INFUSION PUMP
K904923 · Ferguson Medical · Sep 1991
AVI MICRO 210D INFUSION PUMP
K912591 · 3M Avi, Inc. · Sep 1991
INFUSA D.SLT SYRINGE INFUSION PUMP
K904922 · Ferguson Medical · Sep 1991