Cleared Special

K993387 - IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K

K993387 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 Special 510(k) pathway after a 24-day FDA review.

K993387 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
24d
Days
Class 2
Risk

K993387 is an FDA 510(k) clearance for the IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on November 1, 1999 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K993387

510(k) Number K993387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1999
Decision Date November 01, 1999
Days to Decision 24 days
Submission Type Special
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
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 K993387.
SIMS PORTEX ANESTHESIA CATHETER
K994275 · Sims Portex, Inc. · Feb 2000
3.0 ML RESERVOIR, MODEL 103/193
K991936 · Medtronic Minimed · Jan 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB
K994039 · Abbott Laboratories · Dec 1999
IRRIGATION OR INFUSION PUMP K PUMP
K991203 · Kmi Kolster Methods, Inc. · Oct 1999
INFUSION DYNAMICS POWER INFUSER MODEL M100B
K992044 · Infusion Dynamics, Inc. · Sep 1999
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
K991437 · Wells Johnson Co. · Aug 1999