Cleared Traditional

K043299 - MEDLEY PCA MODULE, MODEL 8120

K043299 is an FDA 510(k) clearance for MEDLEY PCA MODULE, manufactured by Alaris Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K043299 · Alaris Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
10d
Days
Class 2
Risk

K043299 is an FDA 510(k) clearance for the MEDLEY PCA MODULE, MODEL 8120. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Alaris Medical Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on December 10, 2004 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. 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 Alaris Medical Systems, Inc. devices

FDA 510(k) Submission Details - K043299

510(k) Number K043299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2004
Decision Date December 10, 2004
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 18
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K043299.
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K092313 · B.Braun Medical, Inc. · Nov 2009
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
K072144 · Smiths Medical MD, Inc. · Mar 2008
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
K051253 · Baxter Healthcare Corp · Jul 2005
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07
K043256 · Hospira, Inc. · Dec 2004
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042800 · Hospira, Inc. · Oct 2004
MEDLEY PCA MODULE, MODEL 8120
K032233 · Alaris Medical Systems, Inc. · Sep 2003