Cleared Traditional

VERIFUSE AMBULATORY PUMP (K902891) - FDA 510(k) Clearance

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

K902891 · Block Medical, Inc. · General Hospital
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Nov 1990
Decision
142d
Days
Class 2
Risk

K902891 is an FDA 510(k) clearance for the VERIFUSE AMBULATORY PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Block Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 21, 1990 after a review of 142 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 Block Medical, Inc. devices

Submission Details

510(k) Number K902891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1990
Decision Date November 21, 1990
Days to Decision 142 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
13d slower than avg
Panel avg: 129d · This submission: 142d
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 232
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K902891.
LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.
K910425 · Baxter Healthcare Corp · Apr 1991
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS
K910523 · Baxter Healthcare Corp · Mar 1991
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K904403 · C.R. Bard, Inc. · Dec 1990
SYRINGE INFUSION PUMP
K903343 · Baxter Healthcare Corp · Nov 1990
BARD MICROBORE ANTI-SIPHON NITRO SET
K900217 · C.R. Bard, Inc. · Oct 1990
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K902432 · Abbott Laboratories · Sep 1990