Cleared Traditional

K897096 - MODEL 404A I.V. INFUSION PUMP ANALYZER

K897096 is an FDA 510(k) clearance for MODEL 404A I.V. INFUSION PUMP ANALYZER, manufactured by Dynatech/Nevada, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K897096 · Dynatech/Nevada, Inc. · General Hospital
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Mar 1990
Decision
84d
Days
Class 2
Risk

K897096 is an FDA 510(k) clearance for the MODEL 404A I.V. INFUSION PUMP ANALYZER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Dynatech/Nevada, Inc. (Carson City, US). The FDA issued a Cleared decision on March 15, 1990 after a review of 84 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 Dynatech/Nevada, Inc. devices

FDA 510(k) Submission Details - K897096

510(k) Number K897096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1989
Decision Date March 15, 1990
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 608
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K897096.
FLO-GARD 6300 BLOOD PUMPING INDICATION
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K900057 · Abbott Laboratories · Mar 1990
AVI MICRO 210CM INFUSION PUMP
K897013 · 3M Company · Mar 1990
FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
K891289 · Baxter Healthcare Corp · Feb 1990
OHMEDA 9000 SYRINGE PUMP
K896023 · Ohmeda Medical · Jan 1990