Cleared Traditional

K874649 - CADD-PLUS(TM) MODEL 5400 AMBULATORY INF...

K874649 is the FDA 510(k) clearance for CADD-PLUS(TM) MODEL 5400 AMBULATORY INF... by Pharmacia Deltec, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K874649 · Pharmacia Deltec, Inc. · General Hospital
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Jan 1988
Decision
67d
Days
Class 2
Risk

K874649 is an FDA 510(k) clearance for the CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 67 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 Pharmacia Deltec, Inc. devices

Submission Details

510(k) Number K874649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1987
Decision Date January 19, 1988
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 444
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K874649.
RATEMINDER V INFUSION PUMP
K875174 · Critikon Company, LLC · Mar 1988
BAXTER BEDSIDE SYSTEM
K874181 · Travenol Laboratories, S.A. · Feb 1988
MINIMED III INFUSION PUMP & UNI-SET ADMIN SET
K874564 · Medtronic Minimed · Feb 1988
MODEL 3000 INFUSION PUMP
K871881 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
AUTO SYRINGE MODEL AS20G INFUSION PUMP
K873746 · Baxter Healthcare Corp · Jan 1988
IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP
K873884 · Y · Jan 1988