# K020655: Deltec Insulin Infusion Pump and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Deltec, Inc.
- Decided: Aug 13, 2002 after 165 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973917 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990801: Minimed 508 Insulin Pump, Medtronic Minimed (1999) Summary page 2.
- K991936: 3.0 ML Reservoir, Model 103/193, Medtronic Minimed (2000) Summary page 2.
- K973917: Cadd-Diplomat PC Communications System and the Cadd- Ambassador Pump Communications System, Sims Deltec, Inc. (1998) Summary page 2.
- K993012: Minimed Com-Station, Hardware-7301; Software-7311, Medtronic Minimed (1999) Summary page 2.

## Recalls of this device
- Mar 10, 2008 · Not classified · Z-1622-2008: Smith Medical discovered an issue with a motor component in specific serial numbers of the Deltec Cozmo Insulin Pump, Model Numbers 1700 and 1800. This issue affects how the motor operates and may cau
- Feb 22, 2008 · Not classified · Z-1590-2008: Smith Medical has received reports of Deltec Cozmo Insulin Pumps powering down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the Pump may power down and a b
- Feb 22, 2008 · Not classified · Z-1591-2008: Smith Medical has received reports of Deltec Cozmo Insulin Pumps powering down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the Pump may power down and a b
- Oct 15, 2004 · Not classified · Z-0566-05: Smiths Medical MD, Inc. (SMMD) has received several complaints relating to two lots of Cozmo Cartridges describing leakage of insulin into the cartridge chamber. Firm expanded recall 03/17/05 to inclu
- Sep 18, 2004 · Not classified · Z-0210-05: The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.
- Mar 14, 2003 · Not classified · Z-0798-03: A software error could have resulted in the delivery of a larger bolus of insulin than anticipated when the pump was programmed in a particular manner.

## Indications for use
The Deltec Cozmo Insulin Infusion Pump Model 1700 is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes. The Deltec Cozmo 3-ml Cartridge is designed for use with the Deltec Cozmo Insulin Infusion Pump for Continuous Subcutaneous Insulin Infusion (CSII). The Deltec Cozmo Treatment Assistant PC Communications System is designed for use with Deltec Cozmo Insulin Infusion Pump as a tool in optimizing diabetes management. It allows communications between the pump and a computer for accessing data stored in pump memory, and programming the pump.

Source page: https://510kreport.com/device/K020655
Methodology: https://510kreport.com/methodology