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Kangaroo OMNI Enteral Feeding Pump - Kangaroo OMNI™ Feeding Set 1000ml (B10FD )
FDA 510(k)Class II (US FDA 510(k))
510(k) K221603
Identifiers
- 510(k) Number
- K221603 FDA 510(k)
- FDA Product Code
- LZH FDA 510(k)
- Models / Variants
- Kangaroo OMNI™ Feeding Set 500ml (B5FD ) FDA 510(k)Kangaroo OMNI™ ENtelliSet 500ml (E5FD ) FDA 510(k)Kangaroo OMNI™ Feeding Set 1000ml (B10FD ) FDA 510(k)Kangaroo OMNI™ ENtelliSet 1000ml (E10FD ) FDA 510(k)Kangaroo OMNI™ ENPlus Spike Set (BSPFD ) FDA 510(k)Kangaroo OMNI™ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Kangaroo OMNI Enteral Feeding Pump - Kangaroo OMNI™ Feeding Set 1000ml (B10FD ) by Cardinal Health, LLC — Class II — FDA_510K — listed in FDA 510(k) — 11…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221603 | Class II | Active |
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Manufacturer
- Manufacturer
- Cardinal Health, LLC
Sources (1)
- FDA 510(k) K221603 24 fields · synced Jun 18, 2026