Mityvac
FDA 510(k) K011532 · Prism Enterprises, Inc.
510(k) numberK011532
Submission
- Device name
- Mityvac
- Applicant
- Prism Enterprises, Inc.
Washington, DC, US - Received
- May 18, 2001
- Decision date
- July 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K981260 | Kiwi Soft Cup with Palm Pump Model Number VFE-6000S, Kiwi Mushroom Cup with Palm Pump…HDB · Traditional | Clinical Innovations, Inc. | 09/22/1998SE |
| 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
Questions and answers
When was Mityvac cleared by the FDA?
Mityvac (K011532) received a 510(k) decision of Substantially Equivalent on July 30, 2001, 73 days after the submission was received.
What is the product code of K011532?
The FDA product code is HDB – Extractor, Vacuum, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.4340.