Cleared Traditional

TFV-2300 INFUSION PUMP (K890736) - FDA 510(k) Clearance

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

K890736 · Nihon Kohden America, Inc. · General Hospital
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Jul 1990
Decision
511d
Days
Class 2
Risk

K890736 is an FDA 510(k) clearance for the TFV-2300 INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on July 9, 1990 after a review of 511 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K890736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date July 09, 1990
Days to Decision 511 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
382d slower than avg
Panel avg: 129d · This submission: 511d
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 234
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K890736.
ABBOTT LIFECARE 4100 PCA INFUSER
K895710 · Abbott Laboratories · Jul 1990
ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP
K895709 · Abbott Laboratories · Jul 1990
RATE INFUSER PLUS
K900742 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
LIFECARE MICRO PUMP (INFUSION PUMP)
K893769 · Abbott Laboratories · Jun 1990
PANCRETEC I.V. MODEL 5000 INFUSER
K895867 · Abbott Laboratories · Jun 1990
FLO-GARD 6300 BLOOD PUMPING INDICATION
K900699 · Baxter Healthcare Corp · Apr 1990