Cleared Traditional

K051568 - CADD-MS 3 AMBULATORY INFUSION PUMP

K051568 is an FDA 510(k) clearance for CADD-MS 3 AMBULATORY INFUSION PUMP, 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 156-day FDA review.

K051568 · Smiths Medical MD, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
156d
Days
Class 2
Risk

K051568 is an FDA 510(k) clearance for the CADD-MS 3 AMBULATORY 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 November 17, 2005 after a review of 156 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 Smiths Medical MD, Inc. devices

FDA 510(k) Submission Details - K051568

510(k) Number K051568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2005
Decision Date November 17, 2005
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
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 628
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K051568.
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
K052221 · Sorenson Medical, Inc. · Dec 2005
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
K050800 · Caesarea Medical Electronics , Ltd. · Nov 2005
CRONO FIVE AND CRONO PCA 50
K052218 · Cane S.R.L. · Nov 2005
ALARIS SYSTEM PC UNIT, MODEL 8001
K051641 · Cardinal Health, Alaris Products · Oct 2005
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
K052171 · Zimmer, Inc. · Oct 2005
CRONO SUPER PID
K052217 · Cane S.R.L. · Sep 2005