Cleared Traditional

K895644 - CADD-PCA AMBULATORY INFUSION PUMPS

K895644 is an FDA 510(k) clearance for CADD-PCA AMBULATORY INFUSION PUMPS, manufactured by Pharmacia Deltec, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K895644 · Pharmacia Deltec, Inc. · General Hospital
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Aug 1990
Decision
322d
Days
Class 2
Risk

K895644 is an FDA 510(k) clearance for the CADD-PCA AMBULATORY INFUSION PUMPS. 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 August 8, 1990 after a review of 322 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 Pharmacia Deltec, Inc. devices

FDA 510(k) Submission Details - K895644

510(k) Number K895644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date August 08, 1990
Days to Decision 322 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
193d slower than avg
Panel avg: 129d · This submission: 322d
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 601
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K895644.
LIFECARE MODEL 4 PUMP
K900467 · Abbott Laboratories · Aug 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · Abbott Laboratories · Aug 1990
CADD-PCA AMBULATORY INFUSION PUMPS
K896075 · Pharmacia Deltec, Inc. · Aug 1990
ENTERA-FLO ENTERAL FEEDING PUMP
K894506 · Delmed, Inc. · Aug 1990
BECTON DICKINSON PROGRAM 2 INFUSION PUMP
K900375 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY
K902092 · Critikon Company, LLC · Jul 1990