Cleared Traditional

K873884 - IVAC MODEL 560+ SERIES VOLUMETRIC INFUS...

K873884 is the FDA 510(k) clearance for IVAC MODEL 560+ SERIES VOLUMETRIC INFUS... by Y. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K873884 · Y · General Hospital
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Jan 1988
Decision
105d
Days
Class 2
Risk

K873884 is an FDA 510(k) clearance for the IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on January 6, 1988 after a review of 105 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 Y devices

Submission Details

510(k) Number K873884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1987
Decision Date January 06, 1988
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 K873884.
CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP
K874649 · Pharmacia Deltec, Inc. · Jan 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
BETATRON IV SYSTEM
K872774 · Cardiac Pacemakers, Inc. · Jan 1988
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K873522 · C.R. Bard, Inc. · Dec 1987
BARD MICROINFUSER I INSULIN INFUSION PUMP
K871807 · C.R. Bard, Inc. · Dec 1987