Cleared Traditional

K061108 - STRYKER AUTO IRRIGATION SYSTEM

K061108 is an FDA 510(k) clearance for STRYKER AUTO IRRIGATION SYSTEM, manufactured by Stryker. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K061108

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.

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 586
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