IMed Products IM100005L
by Integrated Medical Systems, Inc.
IMed Products IM100005L is a Class II device made by Integrated Medical Systems, Inc., cleared under FDA 510(k) K151650 on 4 Apr 2016 and listed in FDA GUDID since 16 Apr 2025 (UDI-DI 00810110920460), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810110920460 | Date16 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151650 | Date4 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 00810110920460
- FDA 510(k) database K151650
Across registries
- FDA 510(k) K151650 decided 4 Apr 2016 Active
- FDA GUDID UDI-DI 00810110920460 listed 16 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K151650
- Listed FDA GUDID 00810110920460
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- IMed Products
- Generic name
- Elastomeric infusion pump system
- Model / Ref / Catalog
- IM100005L
- Primary DI / UDI-DI
- 00810110920460
- 510(k) Number
- FDA product code
- MEB
- GMDN term
- Elastomeric infusion pump system
- Device class
- Class II
- Regulation number
- 880.5725
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Elastomeric infusion pump system.