Cleared Special

K022203 - ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384

K022203 is an FDA 510(k) clearance for ABBOTT LIFECARE PCA 3 INFUSER, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code MEA cleared through the Special 510(k) pathway after a 27-day FDA review.

K022203 · Abbott Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
27d
Days
Class 2
Risk

K022203 is an FDA 510(k) clearance for the ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 27 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K022203

510(k) Number K022203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2002
Decision Date August 01, 2002
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 25
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K022203.
STRYKER PAINPUMP2
K030661 · Stryker Instruments · May 2003
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K020418 · P.T. Greenleaf · Apr 2003
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K020421 · Hennig Enterprises Europe Srl · Apr 2003
MICROJET CRONO PCA
K013822 · Cane S.R.L. · May 2002
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · Baxter Healthcare Corp · Sep 2000
PALM PUMP
K002434 · Sorenson Medical, Inc. · Aug 2000