Cleared Traditional

CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. (K854964) - FDA 510(k) Clearance

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

K854964 · Deltec Systems, Inc. · General Hospital
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Mar 1986
Decision
86d
Days
Class 2
Risk

K854964 is an FDA 510(k) clearance for the CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Deltec Systems, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 7, 1986 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deltec Systems, Inc. devices

Submission Details

510(k) Number K854964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1985
Decision Date March 07, 1986
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 K854964.
BECTON DICKINSON PCAINFUSER
K861007 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1986
FLO-GARD 6200 VOLUMETRIC INFUSION PUMP
K860162 · Travenol Laboratories, S.A. · Apr 1986
MODEL 900 INFUSION PUMP
K860229 · C.R. Bard, Inc. · Apr 1986
BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO
K853629 · C.R. Bard, Inc. · Jan 1986
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · Travenol Laboratories, S.A. · Dec 1985
TRAVENOL MULTIDAY INFUSOR 2C1080
K842905 · Travenol Laboratories, S.A. · Nov 1985