# K040636: Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: May 19, 2004 after 70 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
4 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CADD® Medication Cassette Reservoir: named in the summary without a submission number
- (no number) CADD® Administration Set: named in the summary without a submission number

## Most influential descendants
- K170982: CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (2017), 3 descendants of its own
- K081156: Cadd Medication Cassette Reservoir (2008), 2 descendants of its own
- K232793: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets (2024), 1 descendant of its own
- K162219: CADD® Infusion Disposables Portfolio with NRFit™ connectors (2017), 1 descendant of its own
- K242660: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (2024), 0 descendants of its own

## Recalls of this device
- Aug 6, 2025 · Class II · Z-2522-2025: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along
- Dec 9, 2022 · Class I · Z-0963-2023: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
- Mar 17, 2017 · Class II · Z-1767-2017: Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter
- Apr 22, 2016 · Class II · Z-1831-2016: Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.
- Feb 2, 2015 · Class II · Z-1286-2015: Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication ba
- Dec 14, 2007 · Not classified · Z-0879-2008: Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps

## Indications for use
The CADD® Medication Cassette Reservoir with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids. The CADD® Administration Set with Flow Stop is designed for use with the CADD® pumps (except CADD-Microo and CADD-TPN ) for delivery of medications and fluids.

Source page: https://510kreport.com/device/K040636
Methodology: https://510kreport.com/methodology