# K031361: Cadd High-Volume Administration Sets with Flowstop

- Pathway: 510(k) (Special)
- Applicant: Deltec, Inc.
- Decided: May 23, 2003 after 23 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has 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 High-Volume Administration Sets: named in the summary without a submission number
- (no number) GemStar Pump Set: named in the summary without a submission number

## Most influential descendants
- K172592: CADD Yellow High Volume Administration Set with NRFit connector (2018), 1 descendant of its own
- K221319: BD Alaris™ Pump Epidural Infusion Set (2023), 0 descendants of its own

## Recalls of this device
- Dec 9, 2022 · Class I · Z-0962-2023: 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
- Jul 14, 2020 · Class II · Z-0148-2022: Product may have been manufactured with an air filter assembled in an incorrect orientation.
- May 15, 2017 · Class II · Z-2589-2017: One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24.

## Indications for use
The CADD@High-Volume Administration Set is designed for use with the CADD- Prizm@pump to allow fluid delivery from an IV bag.

Source page: https://510kreport.com/device/K031361
Methodology: https://510kreport.com/methodology