Cleared Traditional

ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT (K023098) - FDA 510(k) Clearance

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

K023098 · Mckinley Infuser · General Hospital
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Dec 2002
Decision
82d
Days
Class 2
Risk

K023098 is an FDA 510(k) clearance for the ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Mckinley Infuser (San Francisco, US). The FDA issued a Cleared decision on December 9, 2002 after a review of 82 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 Mckinley Infuser devices

Submission Details

510(k) Number K023098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2002
Decision Date December 09, 2002
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 129d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEB Pump, Infusion, Elastomeric
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 - MEB Pump, Infusion, Elastomeric

All 13
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K023098.
ON-Q* Pump with Bolus
K181360 · Halyard Health · Mar 2019
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · Baxter Healthcare Corp · May 2007
SEMPERFLO INFUSION SYSTEM
K052999 · Ethicon, Inc. · Mar 2006
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
K021274 · Baxter Healthcare Corp · May 2002
MULTIRATE INFUSOR SV
K011317 · Baxter Healthcare Corp · Jun 2001
DISPOSABLE INFUSION PUMP KIT
K993972 · Biomet, Inc. · Feb 2000