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Deltec Insulin Infusion Pump and Accessories

by Deltec, Inc. 510(k)

Active United States

510(k) K020655

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020655 Date13 Aug 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

6 recalls · FDA

    • Terminated Z-1622-2008 FDA Unclassified (pre-2012) initiated 10 Mar 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 cause an over-delivery of insulin which could result in injury to the user.

    • Terminated Z-1591-2008 FDA Unclassified (pre-2012) initiated 22 Feb 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 brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their blood gl

    • Terminated Z-1590-2008 FDA Unclassified (pre-2012) initiated 22 Feb 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 brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their blood g

    • Terminated Z-0566-05 FDA Unclassified (pre-2012) initiated 15 Oct 2004

    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 include one more lot, based on in-house testing and review of customer complaints.

    • Terminated Z-0210-05 FDA Unclassified (pre-2012) initiated 18 Sep 2004

    The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.

    • Terminated Z-0798-03 FDA Unclassified (pre-2012) initiated 14 Mar 2003

    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.

Specification

510(k)

510(k) Number
FDA Product Code
LZG
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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