Cleared Traditional

K061108 - STRYKER AUTO IRRIGATION SYSTEM

K061108 is the FDA 510(k) clearance for STRYKER AUTO IRRIGATION SYSTEM by Stryker. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K061108 · Stryker · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
288d
Days
Class 2
Risk

K061108 is an FDA 510(k) clearance for the STRYKER AUTO IRRIGATION SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Stryker (Kalamazoo, US). The FDA issued a Cleared decision on February 2, 2007 after a review of 288 days - an extended review 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: 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 devices

Submission Details

510(k) Number K061108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2006
Decision Date February 02, 2007
Days to Decision 288 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
159d slower than avg
Panel avg: 129d · This submission: 288d
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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K061108.
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
K073051 · Medrad, Inc. · May 2008
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
K070398 · Hospira, Inc. · Apr 2007
COLLEAGUE GUARDIAN CONFIGURATION TOOL
K070125 · Baxter Healthcare Corp · Apr 2007
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
K052973 · Baxter Healthcare Corp · Jan 2007
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K062699 · B.Braun Medical, Inc. · Oct 2006
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K062700 · B.Braun Medical, Inc. · Oct 2006