Cleared Traditional

K111275 - CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE

K111275 is an FDA 510(k) clearance for CADD SOLIS VIP AMBULATORY INFUSION PUMP..., manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 637-day FDA review.

K111275 · Smiths Medical Asd, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
637d
Days
Class 2
Risk

K111275 is an FDA 510(k) clearance for the CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFT.... Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 1, 2013 after a review of 637 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Smiths Medical Asd, Inc. devices

FDA 510(k) Submission Details - K111275

510(k) Number K111275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2011
Decision Date February 01, 2013
Days to Decision 637 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
508d slower than avg
Panel avg: 129d · This submission: 637d
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 553
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K111275.
SAPPHIRE INFUSION PUMP
K123049 · Q Core Medical , Ltd. · Oct 2013
KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
K123822 · Hk Surgical, Inc. · Sep 2013
AGILIA INFUSION SYSTEM
K121613 · Fresenius Kabi AG · May 2013
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K122215 · Carticept Medical, Inc. · Oct 2012
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K120830 · Carticept Medical, Inc. · Apr 2012
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
K110535 · Carefusion 303, Inc. · Mar 2012