Cleared Traditional

K080743 - LOCKBOX FOR USE WITH CADD SOLIS INFUSIO...

K080743 is an FDA 510(k) clearance for LOCKBOX FOR USE WITH CADD SOLIS INFUSIO..., manufactured by Smiths Medical MD, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K080743 · Smiths Medical MD, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
39d
Days
Class 2
Risk

K080743 is an FDA 510(k) clearance for the LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 25, 2008 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smiths Medical MD, Inc. devices

FDA 510(k) Submission Details - K080743

510(k) Number K080743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2008
Decision Date April 25, 2008
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 460
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