# K843772: Cadd-1 5100 Ambulatory Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Deltec Systems, Inc.
- Decided: Dec 6, 1984 after 72 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K990091: S.P.a.R Sterile Ambulatory Reservoir (1999), 0 descendants of its own

## Recalls of this device
- Sep 25, 2017 · Class II · Z-0060-2018: Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
- Sep 25, 2017 · Class II · Z-0062-2018: Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
- Sep 25, 2017 · Class II · Z-0061-2018: Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
- Jun 5, 2017 · Class II · Z-3071-2017: The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed
- 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 9, 2008 · Not classified · Z-0987-2009: Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medi
- Dec 14, 2007 · Not classified · Z-0876-2008: Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
- Dec 14, 2007 · Not classified · Z-0878-2008: Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
- Dec 14, 2007 · Not classified · Z-0877-2008: Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
- Jun 18, 2007 · Not classified · Z-1213-2007: Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one 
- Jun 18, 2007 · Not classified · Z-1214-2007: Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one 
- Jun 18, 2007 · Not classified · Z-1215-2007: Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one 

Source page: https://510kreport.com/device/K843772
Methodology: https://510kreport.com/methodology