Cleared Traditional

K050433 - ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM

K050433 is an FDA 510(k) clearance for ZIMMER AMBULATORY PUMP PAIN MANAGEMENT ..., manufactured by Zimmer Orthopaedic Surgical Products. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K050433 · Zimmer Orthopaedic Surgical Products · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
50d
Days
Class 2
Risk

K050433 is an FDA 510(k) clearance for the ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Zimmer Orthopaedic Surgical Products (Dover, US). The FDA issued a Cleared decision on April 13, 2005 after a review of 50 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 - K050433

510(k) Number K050433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2005
Decision Date April 13, 2005
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 779
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K050433.
PAINPUMP2
K043466 · Stryker Instruments · May 2005
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K050324 · Carolina Medical, Inc. · Apr 2005
VEINNOVATIONS INFILTRATION SYSTEM
K050474 · Veinnovations, LLC · Apr 2005
SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
K043204 · Sgarlato Laboratories, Inc. · Mar 2005
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
K043600 · Medtronic Minimed · Mar 2005
SE INFUSION SYSTEM WITH MMS
K043590 · Cardinal Health, Alaris Products · Mar 2005
K050433 · ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM
Download PDF FDA Summary Zimmer Orthopaedic Su…