Cleared Traditional

K060258 - AUTOFUSER

K060258 is an FDA 510(k) clearance for AUTOFUSER, manufactured by Ace Medical Us, LLC. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K060258 · Ace Medical Us, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
118d
Days
Class 2
Risk

K060258 is an FDA 510(k) clearance for the AUTOFUSER. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Ace Medical Us, LLC (Powell, US). The FDA issued a Cleared decision on May 30, 2006 after a review of 118 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.

FDA 510(k) Submission Details - K060258

510(k) Number K060258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2006
Decision Date May 30, 2006
Days to Decision 118 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEB Device Classification - Class 2, Special Controls

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 87
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K060258.
STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
K061661 · Advanced Infusion, Inc. · Oct 2006
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457 · Baxter Healthcare Corporation · Sep 2006
SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET
K061409 · Precise Medical Products, Ltd. · Jun 2006
SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
K060933 · Apex Medical Technologies, Inc. · May 2006
SEMPERFLO INFUSION SYSTEM
K052999 · Ethicon, Inc. · Mar 2006
NIPRO SUREFUSER AMBULATORY INFUSION PUMP
K051828 · Nipro Medical Corporation · Dec 2005
K060258 · AUTOFUSER
Download PDF FDA Summary Ace Medical Us, LLC