MODEL IR 1200 INSULIN PUMP
FDA 510(k) clearance K032257 · decided 2003-10-16
Clearance details
- K-number
- K032257
- Device name
- MODEL IR 1200 INSULIN PUMP
- Applicant
- Animas Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-22
- Decision date
- 2003-10-16
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Frazer, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Animas Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps In recall (Z-0836-2013) | Animas Corporation | 2013-02-17 |
| IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management recall (Z-0005-2013) | Animas Corporation | 2012-10-02 |
| 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion recall (Z-1678-2011) | Animas Corporation | 2011-05-10 |
| Animas IR 1200 Intended use:deliver insulin therapy recall (Z-2396-2010) | Animas Corporation | 2010-09-10 |
| Battery Caps used with Animas IR1200 Insulin Pump. The pump is used to help maintain blood recall (Z-0293-2009) | Animas Corporation | 2008-11-25 |
| Isulin Pump. Model IR1200 recall (Z-0308-06) | Animas Corporation | 2005-12-23 |
| IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C. recall (Z-0211-05) | Animas Corporation | 2004-11-19 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Animas Vibe System (P130007/S036) | Animas Corp. | 2018-07-11 |
| Animas Vibe System (P130007/S035) | Animas Corp. | 2018-04-18 |
| Animas Vibe System (P130007/S034) | Animas Corp. | 2018-03-12 |
| Animas Vibe System (P130007/S033) | Animas Corp. | 2018-03-01 |
| Animas Vibe System (P130007/S027) | Animas Corp. | 2017-10-27 |
| Animas Vibe System (P130007/S031) | Animas Corp. | 2017-10-24 |
| Animas Vibe System (P130007/S029) | Animas Corp. | 2017-08-17 |
| Animas, Vibe System (P130007/S026) | Animas Corp. | 2017-06-09 |