Cleared Special

6060 MULTI-THERAPY PUMP, MODEL 2M9832 (K002679) - FDA 510(k) Clearance

Also marketed or referenced as:
6060 EPIDURAL PUMP, MODEL 2L9351

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K002679 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
21d
Days
Class 2
Risk

K002679 is an FDA 510(k) clearance for the 6060 MULTI-THERAPY PUMP, MODEL 2M9832. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 18, 2000 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K002679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2000
Decision Date September 18, 2000
Days to Decision 21 days
Submission Type Special
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
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 219
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K002679.
ABBOTT ACCLAIM ENCORE, MODEL 12237
K011096 · Abbott Laboratories · May 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · Abbott Laboratories · Apr 2001
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
K003616 · Baxter Healthcare Corp · Dec 2000
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
K002380 · Baxter Healthcare Corp · Sep 2000
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
K002211 · Baxter Healthcare Corp · Jul 2000
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · Abbott Laboratories · Jul 2000