Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
FDA 510(k) clearance K250298 · decided 2025-10-08
Clearance details
- K-number
- K250298
- Device name
- Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
- Applicant
- Clinical Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-01-31
- Decision date
- 2025-10-08
- Days to decision
- 250 days
- Clearance type
- Traditional
- Product code
- HDB
- Device class
- 2
- Regulation number
- 884.4340
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Murray, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDELA SINGLE USE SILC CUP, MODEL 077.0791 (K041579) | Medela AG | 2005-04-21 |
| VACULINK, MODEL VCL 3000 (K043614) | Medevco, Inc. | 2005-04-14 |
| FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 (K021193) | Fortune Medical Instrument Corp. | 2003-02-12 |
| MITYVAC MERLIN, MODEL 10027 (K020447) | Prism Enterprises, Inc. | 2002-04-12 |
| SWIFT LOW PROFILE CUP (PRO CUP) (K013460) | Swift Delivery Products | 2002-01-17 |
| MITYVAC (K011532) | Prism Enterprises, Inc. | 2001-07-30 |
| KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M (K981260) | Clinical Innovations, Inc. | 1998-09-22 |
| AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP (K980976) | Hollister, Inc. | 1998-08-21 |
| MITYVAC (K980212) | Prism Technologies, Inc. | 1998-07-09 |
| SWIFT DELIVERY PRODUCT #300 (K973942) | Swift Delivery Products | 1997-12-12 |
| SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE (K970170) | Richard G. Lindsay | 1997-03-28 |
| VACUUM CUP (004SD) (K963287) | Swift Delivery Products | 1996-10-28 |
Recalls involving this device
No recalls on record reference this clearance.