Cleared Traditional

K023264 - MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110

K023264 is an FDA 510(k) clearance for MEDLEY SYRINGE PUMP MODULE SYSTEM, manufactured by Alaris Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K023264 · Alaris Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
80d
Days
Class 2
Risk

K023264 is an FDA 510(k) clearance for the MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Alaris Medical Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on December 19, 2002 after a review of 80 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.

FDA 510(k) Submission Details - K023264

510(k) Number K023264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date December 19, 2002
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 675
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K023264.
AUTOMED 3000 INFUSION PUMP
K023863 · Help Technologies · Feb 2003
SURESET 3.0 ML RESERVOIR, MODEL 24-103
K024056 · Applied Diabetes Research, Incorporated · Jan 2003
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · Abbott Laboratories · Dec 2002
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
K023491 · Help Technologies · Dec 2002
PARAGON INFUSION SYSTEM WITH BOLUS
K023827 · I-Flow Corp. · Dec 2002
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
K023062 · Abbott Laboratories, Inc. · Sep 2002
K023264 · MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
Download PDF FDA Summary Alaris Medical System…