Cleared Traditional

K031566 - SYNDEO PCA SYRINGE PUMP, MODEL 2L3113

K031566 is an FDA 510(k) clearance for SYNDEO PCA SYRINGE PUMP, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K031566 · Baxter Healthcare Corp · General Hospital
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Aug 2003
Decision
92d
Days
Class 2
Risk

K031566 is an FDA 510(k) clearance for the SYNDEO PCA SYRINGE PUMP, MODEL 2L3113. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Deerfield Lake, US). The FDA issued a Cleared decision on August 19, 2003 after a review of 92 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.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K031566

510(k) Number K031566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2003
Decision Date August 19, 2003
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 21
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K031566.
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
STRYKER PAINPUMP2
K030661 · Stryker Instruments · May 2003
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · Abbott Laboratories · Aug 2002
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · Baxter Healthcare Corp · Sep 2000