Cleared Traditional

SITESCRUB IPA DEVICE (K112791) - FDA 510(k) Clearance

K112791 · C. R. Bard · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
151d
Days
-
Risk

K112791 is an FDA 510(k) clearance for the SITESCRUB IPA DEVICE. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by C. R. Bard (Salt Lake Ciy,, US). The FDA issued a Cleared decision on February 24, 2012 after a review of 151 days - an extended review cycle.

This device falls under the General Hospital FDA review panel. 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 C. R. Bard devices

Submission Details

510(k) Number K112791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date February 24, 2012
Days to Decision 151 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 129d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKB Pad, Alcohol, Device Disinfectant
Device Class -