# K062323: Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815, 21-1816, 21-1817

- Pathway: 510(k) (Special)
- Applicant: Smiths Medical MD, Inc.
- Decided: Nov 1, 2006 after 84 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
1 of 14 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) Deltec Cozmo® Insulin Pump Model 1700: named in the summary without a submission number
- (no number) Animas IR 1250: named in the summary without a submission number

## Most influential descendants
- K071613: Amigo Insulin Pump (2007), 10 descendants of its own
- K111210: T:Slim (TM) Insulin Delivery System (2011), 9 descendants of its own
- K133593: T:Slim Insulin Delivery System (2014), 8 descendants of its own
- K141758: T:Slim Insulin Delivery System (2014), 7 descendants of its own
- K160056: t:slim Insulin Delivery System (2016), 4 descendants of its own

## Recalls of this device
- Nov 20, 2008 · Not classified · Z-0989-2009: Smiths Medical has become aware of a display irregularity with the Deltec Cozmo Insulin Pump, Model 1800 and Model 21-1700 containing Model 1800 software. There have been adverse events reported that 
- Nov 20, 2008 · Not classified · Z-0988-2009: Smiths Medical has become aware of a display irregularity with the Deltec Cozmo Insulin Pump, Model 1800 and Model 21-1700 containing Model 1800 software. There have been adverse events reported that 
- Mar 10, 2008 · Not classified · Z-1623-2008: 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
- 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-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

## Indications for use
The Deltec Cozmo® Insulin Pump is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes. The Deltec CoZmonitorTM Blood Glucose Monitor is available as an accessory to be used solely with the Deltec Cozmo® Insulin Pump. Because the monitor is powered by FreeStyleTM, blood sampling can be performed using the finger, forearm, upper arm, thigh, calf or hand. All testing is performed outside of the body (in other words, in-vitro diagnostic use only). Use only with FreeStyleTM Test Strip and FreeStyleTM Control Solution, as other products can give inaccurate results. The Deltec CoZmonitorTM Blood Glucose Monitoring System is designed to be used only with the Deltec Cozmo® Insulin Pump to help you and your healthcare provider monitor your diabetes management program. When used properly, the monitor provides a quantitative measurement of glucose (or sugar) in whole blood. Because the monitor is powered by FreeStyleTM, blood sampling can be performed using the finger, forearm, upper arm, thigh, calf or hand. All testing is performed outside of the body (in other words, in-vitro diagnostic use only). Use only with FreeStyleTM Test Strip and FreeStyleTM Control Solution, as other products can give inaccurate results.

Source page: https://510kreport.com/device/K062323
Methodology: https://510kreport.com/methodology