Cleared Traditional

K031249 - MODIFICATION TO STRYKER PAINPUMP

K031249 is an FDA 510(k) clearance for MODIFICATION TO STRYKER PAINPUMP, manufactured by Stryker Instruments. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K031249 · Stryker Instruments · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
94d
Days
Class 2
Risk

K031249 is an FDA 510(k) clearance for the MODIFICATION TO STRYKER PAINPUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on July 21, 2003 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Instruments devices

FDA 510(k) Submission Details - K031249

510(k) Number K031249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2003
Decision Date July 21, 2003
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
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 581
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K031249.
MEDRAD CONTINUUM MR INFUSION SYSTEM
K032771 · Medrad, Inc. · Sep 2003
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K032005 · Medtronic Minimed · Aug 2003
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
K032147 · Alaris Medical Systems, Inc. · Jul 2003
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
K030576 · The Anspach Effort, Inc. · May 2003
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
K031185 · Abbott Laboratories · Apr 2003
MODIFICATION TO STRYKER PAINPUMP2
K030885 · Stryker Instruments · Apr 2003