Kiwi Soft Cup with Palm Pump Model Number VFE-6000S, Kiwi Mushroom Cup with Palm Pump Model VFE-6000M
FDA 510(k) K981260 · Clinical Innovations, Inc.
510(k) numberK981260
Submission
- Device name
- Kiwi Soft Cup with Palm Pump Model Number VFE-6000S, Kiwi Mushroom Cup with Palm Pump Model VFE-6000M
- Applicant
- Clinical Innovations, Inc.
Murray, UT, US - Received
- April 6, 1998
- Decision date
- September 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HDB – Extractor, Vacuum, Fetal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4340
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HDB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum…HDB · Traditional | Clinical Innovations, LLC | 10/08/2025SE |
| K041579 | Medela Single Use Silc Cup, Model 077.0791HDB · Traditional | Medela AG | 04/21/2005SE |
| K043614 | Vaculink, Model VCL 3000HDB · Traditional | Medevco, Inc. | 04/14/2005SE |
| K021193 | Fortune Silicone Vacuum Suction, Model #1300HDB · Traditional | Fortune Medical Instrument Corp. | 02/12/2003SE |
| K020447 | Mityvac Merlin, Model 10027HDB · Special | Prism Enterprises, Inc. | 04/12/2002SE |
| K013460 | Swift Low Profile Cup (Pro Cup)HDB · Traditional | Swift Delivery Products | 01/17/2002SE |
| K011532 | MityvacHDB · Special | Prism Enterprises, Inc. | 07/30/2001SE |
| K980976 | Ameda Disposable Vacuum Assist Cup with Fluid Retention TrapHDB · Traditional | Hollister, Inc. | 08/21/1998SE |
| K980212 | MityvacHDB · Traditional | Prism Technologies, Inc. | 07/09/1998SE |
| K973942 | Swift Delivery Product #300HDB · Traditional | Swift Delivery Products | 12/12/1997SE |
More from Swift Delivery Products
| 510(k) | Device | Decision |
|---|---|---|
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum…HDB · Traditional | 10/08/2025SE |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E)HFN · Traditional | 05/22/2025SE |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP)FMK · Traditional | 02/24/2023SE |
| K153591 | ebb Complete Tamponade SystemOQY · Special | 01/14/2016SE |
| K150573 | ebb Complete Tamponade SystemOQY · Special | 03/25/2015SE |
| K140163 | Koala TocoHFM · Traditional | 05/29/2014SE |
| K131781 | Clearview TotalLKF · Traditional | 05/28/2014SE |
| K110605 | Rom PlusNQM · Traditional | 11/23/2011SE |
| K061539 | Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional | 09/20/2007SE |
| K030691 | Fetal Spiral Electrode, Model FSE07000HGP · Traditional | 09/17/2003SE |
Questions and answers
When was Kiwi Soft Cup with Palm Pump Model Number VFE-6000S, Kiwi Mushroom Cup with Palm Pump Model VFE-6000M cleared by the FDA?
Kiwi Soft Cup with Palm Pump Model Number VFE-6000S, Kiwi Mushroom Cup with Palm Pump Model VFE-6000M (K981260) received a 510(k) decision of Substantially Equivalent on September 22, 1998, 169 days after the submission was received.
What is the product code of K981260?
The FDA product code is HDB – Extractor, Vacuum, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.4340.