Animas Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Animas Corp.” (first 2000, latest 2008), plus 2 PMA decisions, across 6 product codes in 2 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZG | Pump, Infusion, Insulin | 7 | 7 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| KZH | Introducer, Syringe Needle | 1 | 1 |
| MRZ | Accessories, Pump, Infusion | 1 | 1 |
| NCT | Instrument, Glucose, Noninvasive Technology | 1 | 0 |
| OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 1 | 0 |
Review panels
Most recent Animas Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080639 | SYMPHONY GLUCOSE MANAGEMENT SYSTEM | LZG | 2008-06-24 | 110 |
| K080587 | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE | MRZ | 2008-05-15 | 73 |
| K063674 | EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE | LZG | 2007-03-30 | 109 |
| K042873 | ANIMAS MODEL IR1250 INSULIN INFUSION PUMP | LZG | 2004-12-10 | 53 |
| K032257 | MODEL IR 1200 INSULIN PUMP | LZG | 2003-10-16 | 86 |
| K022394 | EZMANAGER PLUS | LZG | 2003-06-05 | 317 |
| K021700 | ANIMUS EZSERTER INFUSION SET INSERTER | KZH | 2002-06-04 | 12 |
| K021439 | MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO | LZG | 2002-05-29 | 23 |
| K012754 | EZ SET INFUSION SET | FPA | 2001-08-27 | 11 |
| K993184 | R1000 SERIES INSULIN PUMP | LZG | 2000-02-10 | 140 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130007 | PMA | ANIMAS VIBE SYSTEM | 2014-11-25 |
| P990026 | PMA | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | 2001-03-22 |
Recalls
28 product recalls in 18 recall events; 0 initiated in the last five years. Most recent: 2014-06-10.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Animas Corp. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01919385: Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia (Completed, started 2013-07)
- NCT01638299: Study Assessing an Insulin Pump-controlling Algorithm to Minimize Hypo and Hyper in Type 1 During CRC Setting (Completed, started 2012-07)
- NCT01401751: Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting (Completed, started 2011-07-01)
- NCT00922649: Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes (Completed, started 2008-02-01)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Animas Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRZ)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via OYC)
Frequently asked questions
How many FDA 510(k) clearances are listed under Animas Corp.?
FDA lists 10 510(k) clearances under the applicant name “Animas Corp.” (first 2000, latest 2008), plus 2 PMA decisions, across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Animas Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Animas Corp. is 80 days.
Which FDA product codes appear under Animas Corp.?
The most frequent FDA product codes under this applicant name are LZG (Pump, Infusion, Insulin, 7); FPA (Set, Administration, Intravascular, 1); KZH (Introducer, Syringe Needle, 1).
Next steps
- See all 10 Animas Corp. clearances with predicates and recalls
- Run predicate analysis for product code LZG, Animas Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.