QUICK-SERTER, MODEL 395
FDA 510(k) clearance K992300 · decided 1999-07-29
Clearance details
- K-number
- K992300
- Device name
- QUICK-SERTER, MODEL 395
- Applicant
- Medtronic Minimed
- Decision
- Substantially Equivalent
- Date received
- 1999-07-08
- Decision date
- 1999-07-29
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- KZH
- Device class
- 2
- Regulation number
- 880.6920
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sylmar, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GripMate (K243232) | Synthon Hispania S.L. | 2024-12-02 |
| AccuSert Needle Inserter (K213429) | Emed Technologies Corporation | 2022-10-20 |
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| MiniMed Quick-serter (K160860) | Medtronic Minimed | 2016-09-22 |
| WHISPERJECT AUTOINJECTOR (K141384) | Scandinavian Health Limited | 2014-09-12 |
| LOBSTER AUTO-INJECTOR (K124026) | Scandinavian Health Limited | 2013-09-13 |
| AUTOJECT 2 FOR GLASSY SYRINGE (K122837) | Owen Mumford, Ltd. | 2012-10-15 |
| FLEXI-Q DV AND DVR AUTO-INJECTORS (K111467) | Elcam Medical Acal | 2012-02-09 |
| AUTO-SAFETY INJECTOR-2 (ASI-2) (K082587) | Medical House Products Limited | 2008-10-02 |
| COMPACT AUTO-SAFETY INJECTOR (CASI) (K073476) | Medical House (Asi) Limited | 2008-03-07 |
| DERMOTHERAP GUN (K062339) | Dermoequipos S.R.L. | 2007-02-05 |
| ACCU-CHEK LINKASSIST (K063146) | Disetronic Medical Systems AG | 2006-11-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Simplera System (P160007/S059) | Medtronic Minimed | 2025-12-08 |
| Simplera System (P160007/S057) | Medtronic Minimed | 2025-12-05 |
| Medtronic MiniMed 630G System (P150001/S110) | Medtronic Minimed | 2025-10-16 |
| Guardian Connect System Simplera System (P160007/S056) | Medtronic Minimed | 2025-10-16 |
| Guardian Connect System (P160007/S054) | Medtronic Minimed | 2025-10-09 |
| Simplera System (P160007/S055) | Medtronic Minimed | 2025-09-12 |
| Guardian Connect system (P160007/S053) | Medtronic Minimed | 2025-08-25 |
| Simplera (TM) System (P160007/S052) | Medtronic Minimed | 2024-09-17 |