510(k) · Cleared
Recalled · 2005Model R1000 IR Insulin Pump, Ezlink Software, Sermon Software, R1000 IR Download Cradle, and Serial Interface Adaptor DO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Animas Corp. · LZG Pump, Infusion, Insulin
Cleared on May 29, 2002 after a 23-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- May 29, 2002
- Review
- 23 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
Planning a device in LZG? 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? (1)
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 |
|---|---|---|---|
| * | — | Animas R1000 Series Insulin Infusion Pump Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2005 | Not classified | Z-0307-06 | Other | Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure. |
No ancestor or descendant has a Class I recall.
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 Animas Model Model R1000 IR Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. The accessories to the Model R1000 IR, the Animas RS-232 IR serial interface adator (the “dongle”), the Animas R1000 IR cradle to hold the pump and the Animas ezLink™ software are intended to transfer data stored in the pump to the personal computer of a patient or a physician, where it may be displayed, printed, and saved.
This device is intended for home use and is a prescription device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021439 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021439: Model R1000 IR Insulin Pump, Ezlink Software, Sermon Software, R1000 IR Download Cradle, and Serial Interface Adaptor DO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021439
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026