Cleared Traditional

K072955 - CADD-SENTRY PRO MEDICATION SAFETY SOFTW...

K072955 is an FDA 510(k) clearance for CADD-SENTRY PRO MEDICATION SAFETY SOFTW..., manufactured by Smiths Medical MD, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K072955 · Smiths Medical MD, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2008
Decision
117d
Days
Class 2
Risk

K072955 is an FDA 510(k) clearance for the CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF .... Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 13, 2008 after a review of 117 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 Smiths Medical MD, Inc. devices

FDA 510(k) Submission Details - K072955

510(k) Number K072955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2007
Decision Date February 13, 2008
Days to Decision 117 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
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, 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 - MRZ Accessories, Pump, Infusion

All 18
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K072955.
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