ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
FDA 510(k) clearance K162165 · decided 2017-08-29
Clearance details
- K-number
- K162165
- Device name
- ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
- Applicant
- Summit Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-08-03
- Decision date
- 2017-08-29
- Days to decision
- 391 days
- Clearance type
- Traditional
- Product code
- MEA
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sandy, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 recall (Z-1684-2023) | Avanos Medical, Inc. | 2023-06-06 |
| AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 recall (Z-1685-2023) | Avanos Medical, Inc. | 2023-06-06 |
| SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 recall (Z-1686-2023) | Avanos Medical, Inc. | 2023-06-06 |
| SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 recall (Z-1687-2023) | Avanos Medical, Inc. | 2023-06-06 |
| ambIT Cassette Filter Male Luer, Product Code: 220266 recall (Z-1688-2023) | Avanos Medical, Inc. | 2023-06-06 |