Cleared Traditional

K053226 - ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER

K053226 is an FDA 510(k) clearance for ZIMMER AMBULATORY PUMP PAIN MANAGEMENT ..., manufactured by Zimmer, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K053226 · Zimmer, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
75d
Days
Class 2
Risk

K053226 is an FDA 510(k) clearance for the ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND.... Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Zimmer, Inc. (Dover, US). The FDA issued a Cleared decision on January 31, 2006 after a review of 75 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K053226

510(k) Number K053226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2005
Decision Date January 31, 2006
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
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 580
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K053226.
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
K061128 · Medrad, Inc. · May 2006
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087
K060806 · Hospira, Inc. · Apr 2006
WILLCARE, MODEL GW-1020
K052594 · Icu Medical, Inc. · Feb 2006
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
K050800 · Caesarea Medical Electronics , Ltd. · Nov 2005
CADD-MS 3 AMBULATORY INFUSION PUMP
K051568 · Smiths Medical MD, Inc. · Nov 2005
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
K052171 · Zimmer, Inc. · Oct 2005