Cleared Traditional

K881079 - UVP VOLUMED 2001

K881079 is the FDA 510(k) clearance for UVP VOLUMED 2001 by Ferguson Medical. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K881079 · Ferguson Medical · General Hospital
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Oct 1988
Decision
225d
Days
Class 2
Risk

K881079 is an FDA 510(k) clearance for the UVP VOLUMED 2001. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 225 days - an extended review 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: 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 Ferguson Medical devices

Submission Details

510(k) Number K881079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1988
Decision Date October 25, 1988
Days to Decision 225 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
96d slower than avg
Panel avg: 129d · This submission: 225d
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 447
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K881079.
FLO-GARD VP
K884014 · Baxter Healthcare Corp · Dec 1988
BARD INFUSOR PUMP
K883577 · C.R. Bard, Inc. · Nov 1988
BIOSEARCH 3600 ENTRI FEEDING PUMP
K883587 · Biosearch Medical Products, Inc. · Nov 1988
MULTI-DRUG INFUSION SYSTEM
K883003 · I-Flow Corp. · Oct 1988
BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
K882556 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
BARD PCA II INFUSION PUMP
K880733 · C.R. Bard, Inc. · Jun 1988