PMA · Approved
Recalled · Class II · 2011Animas Vibe System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Animas Corp. · OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Approved on Nov 25, 2014 through premarket approval, which rests on the device’s own clinical evidence after a 587-day review. It has been recalled once.
- Decided
- Nov 25, 2014
- Review
- 587 days
- Class
- Class III
- Product code
- OYC
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P130007 has 30 supplements since 2015: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2015 | 9 |
| 2016 | 11 |
| 2017 | 6 |
| 2018 | 4 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OYC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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 |
|---|---|---|---|---|
| Sep 6, 2011 | Class II | Z-1034-2015 | Software design (manufacturing process) | Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All OYC devicesOYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OYC
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · OYC
Too few OYC 510(k)s in any year since 2007 to give a median.
Recalls per year · OYC
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OYC
12,223in 2025
MAUDE reports naming product code OYC, 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 | 0 | — | 0 | 34 |
| 2008 | 0 | — | 0 | 54 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 7,387 |
| 2013 | 0 | — | 0 | 14,265 |
| 2014 | 1 | — | 0 | 64,913 |
| 2015 | 1 | — | 2 | 105,309 |
| 2016 | 17 | — | 0 | 96,960 |
| 2017 | 13 | — | 0 | 132,643 |
| 2018 | 9 | — | 0 | 106,242 |
| 2019 | 2 | — | 0 | 99,202 |
| 2020 | 0 | — | 0 | 74,582 |
| 2021 | 0 | — | 0 | 50,917 |
| 2022 | 0 | — | 1 | 77,938 |
| 2023 | 0 | — | 0 | 24,388 |
| 2024 | 0 | — | 1 (1) | 17,602 |
| 2025 | 0 | — | 0 | 12,223 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P130007 · printed Nov 4, 2026
Cite this page
510(k) Report. “P130007: Animas Vibe System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P130007
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026