Cleared Traditional

K052973 - IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K

K052973 is an FDA 510(k) clearance for IPUMP PAIN MANAGEMENT SYSTEM, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 458-day FDA review.

K052973 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K052973

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.

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 601
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K052973.
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
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K062592 · Smiths Medical MD, Inc. · Nov 2006
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
K063288 · Cardinal Health 303,Inc. · Nov 2006
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K062699 · B.Braun Medical, Inc. · Oct 2006