Cleared Traditional

IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K (K052973) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052973 · Baxter Healthcare Corp · General Hospital
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Jan 2007
Decision
458d
Days
Class 2
Risk

K052973 is an FDA 510(k) clearance for the IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on January 25, 2007 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K052973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2005
Decision Date January 25, 2007
Days to Decision 458 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
329d slower than avg
Panel avg: 129d · This submission: 458d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 219
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K052973.
Perfusor® Space Syringe Infusion Pump System
K172831 · B.Braun Medical, Inc. · Jun 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
K173084 · Baxter Healthcare Corporation · May 2018
COLLEAGUE GUARDIAN CONFIGURATION TOOL
K070125 · Baxter Healthcare Corp · Apr 2007
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
K053226 · Zimmer, Inc. · Jan 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
K052171 · Zimmer, Inc. · Oct 2005
PUMP CONNECTIVITY INTERFACE
K040985 · Baxter Healthcare Corp · Nov 2004