510(k) · Cleared
Recalled · 2008Deltec Insulin Infusion Pump and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deltec, Inc. · LZG Pump, Infusion, Insulin
Cleared on Aug 13, 2002 as substantially equivalent to K990801 (Medtronic Minimed, 1999) and 3 other predicates after a 165-day review. Its family tree reaches back 1 generation to 1998. 1 of the 5 devices in its family, counting itself, has a Class I recall. It has been recalled 6 times.
- Decided
- Aug 13, 2002
- Review
- 165 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 6
- Predicates
- 4
Its longest line of descent runs back 1 generation to K973917 (1998). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK973917 Cadd-Diplomat PC Communications System and the Cadd- Ambassador Pump…Sims Deltec, Inc. · 1998 · Recalled
- This deviceK020655 Deltec Insulin Infusion Pump and AccessoriesDeltec, Inc. · 2002
Class I recalls in this family
- K990801 Minimed 508 Insulin Pumpdirect predicate · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973917 | Cadd-Diplomat PC Communications System and the Cadd- Ambassador Pump… | Sims Deltec, Inc. | 1998 | 1 |
| 0 (this device) | K020655 | Deltec Insulin Infusion Pump and Accessories | Deltec, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 1 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZG device
- #1 K253534 Pivot Insulin Delivery Systemscore 16.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990801 | Minimed 508 Insulin PumpSummary page 2…p. IV. DEVICE COMPARISON The Deltec CozmoTMInsulin Infbsion Pump is similar in design, fhnction, and intended use to the MiniMed Model 508 Insulin Pump (K990801). The pumps are small, ambulatory, battery-powered, microprocessor controlled, external insulin syringe pump delivery… | 1999 |
| * | K991936 | 3.0 ML Reservoir, Model 103/193Summary page 2…, IR windows, and 3-ml medication cartridge. The Deltec Cozmom 3-ml Cartridge is similar in design, hnction, and intended use to the MiniMed 3-ml Reservoir 6991936). Each device is a syringe style reservoir with a capacity of 3 ml. They are made of the same materials and both are provid… | 2000 |
| * | K973917 | Cadd-Diplomat PC Communications System and the Cadd- Ambassador Pump Communications SystemSummary page 2…p. The Deltec CozmoTMTreatment AssistanP PC Communications System is similar in design, fbnction, and intended use to the Deltec CADD-Diplomat@System (K9739 17). The products allow communications between a personal computer (PC) and an inhsion pump. The software programs allow for d… | 1998 |
| * | K993012 | Minimed Com-Station, Hardware-7301; Software-7311Summary page 2…mming of the pump via a PC. The Deltec Cornom Treatment Assistantm PC Communications System is also similar to the MiniMed Com-Stationm Communication System 6993012), which uses IR communication. 510(k) Summary of Safety and Effec… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 10, 2008 | Not classified | Z-1622-2008 | Component change control | 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… |
| Feb 22, 2008 | Not classified | Z-1590-2008 | Device Design | 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… |
| Feb 22, 2008 | Not classified | Z-1591-2008 | Device Design | 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… |
| Oct 15, 2004 | Not classified | Z-0566-05 | Other | 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… |
| Sep 18, 2004 | Not classified | Z-0210-05 | Other | 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 | Other | 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. |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K990801Minimed 508 Insulin PumpMedtronic Minimed · 1999 · Direct predicate · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K990801.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LZG
116in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZG
1in 2022
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · LZG
12,004in 2025
MAUDE reports naming product code LZG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 112 | 1 | 5,110 |
| 2008 | 6 | 129 | 13 | 5,711 |
| 2009 | 2 | — | 2 | 9,471 |
| 2010 | 2 | — | 4 | 10,175 |
| 2011 | 4 | 189 | 2 | 12,858 |
| 2012 | 3 | 73 | 4 | 18,367 |
| 2013 | 2 | — | 3 (1) | 30,059 |
| 2014 | 4 | 123 | 2 (1) | 49,188 |
| 2015 | 1 | — | 2 (2) | 69,136 |
| 2016 | 4 | 116 | 0 | 56,581 |
| 2017 | 1 | — | 0 | 44,472 |
| 2018 | 1 | — | 3 (2) | 32,652 |
| 2019 | 2 | — | 5 | 29,027 |
| 2020 | 0 | — | 0 | 32,588 |
| 2021 | 1 | — | 0 | 31,522 |
| 2022 | 1 | — | 1 (1) | 28,225 |
| 2023 | 1 | — | 0 | 21,972 |
| 2024 | 2 | — | 0 | 18,228 |
| 2025 | 0 | — | 0 | 12,004 |
| 2026 | 2 | — | 2 (2) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020655: Deltec Insulin Infusion Pump and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020655
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026