Cleared Traditional

K881590 - ADFUSE(TM)

K881590 is an FDA 510(k) clearance for ADFUSE(TM), manufactured by Healthtek, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K881590 · Healthtek, Inc. · General Hospital
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May 1988
Decision
40d
Days
Class 2
Risk

K881590 is an FDA 510(k) clearance for the ADFUSE(TM). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Healthtek, Inc. (Nevada City, US). The FDA issued a Cleared decision on May 23, 1988 after a review of 40 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 Healthtek, Inc. devices

FDA 510(k) Submission Details - K881590

510(k) Number K881590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1988
Decision Date May 23, 1988
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
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 466
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K881590.
MULTI-DRUG INFUSION SYSTEM
K883003 · I-Flow Corp. · Oct 1988
BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
K882556 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
BARD PCA II INFUSION PUMP
K880733 · C.R. Bard, Inc. · Jun 1988
IVAC VOLUMETRIC PUMP - MODEL 590
K875332 · Y · May 1988
SIM MODULE
K874546 · Critikon Company, LLC · May 1988
CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP
K880204 · Pharmacia Deltec, Inc. · Apr 1988