Cleared Special

K002739 - INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K

K002739 is an FDA 510(k) clearance for INFUSOR PATIENT CONTROL MODULE, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code MEA cleared through the Special 510(k) pathway after a 10-day FDA review.

K002739 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
10d
Days
Class 2
Risk

K002739 is an FDA 510(k) clearance for the INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 11, 2000 after a review of 10 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.

FDA 510(k) Submission Details - K002739

510(k) Number K002739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2000
Decision Date September 11, 2000
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

MEA Device Classification - Class 2, Special Controls

Product Code MEA Pump, Infusion, Pca
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 - MEA Pump, Infusion, Pca

All 30
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K002739.
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K020421 · Hennig Enterprises Europe Srl · Apr 2003
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · Abbott Laboratories · Aug 2002
MICROJET CRONO PCA
K013822 · Cane S.R.L. · May 2002
PALM PUMP
K002434 · Sorenson Medical, Inc. · Aug 2000
AVIA PAIN MEDICATION DELIVERY SYSTEM
K990312 · Amtec Medical · Apr 1999
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839 · Sims Deltec, Inc. · Nov 1998
K002739 · INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
Download PDF FDA Summary Baxter Healthcare Corp