Medela Suction Pump
FDA 510(k) K830012 · Medela, Inc.
510(k) numberK830012
Submission
- Device name
- Medela Suction Pump
- Applicant
- Medela, Inc.
Mchenry, IL, US - Received
- January 3, 1983
- Decision date
- January 24, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Prism Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253510 | Freestyle Mini Hands-freeHGX · Traditional | 04/10/2026SE |
| K253149 | Motion InBra (YM-8801) wearable breast pumpHGX · Traditional | 02/13/2026SE |
| K253498 | Pump In Style® Pro+HGX · Special | 01/22/2026SE |
| K251377 | Magic InBraHGX · Traditional | 09/18/2025SE |
| K232608 | Duo Hands-free Breast PumpHGX · Special | 04/12/2024SE |
| K223388 | Invia® Integrated DressingOMP · Traditional | 07/07/2023SE |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | 07/26/2022SE |
| K210759 | Solo, Swing MaxiHGX · Traditional | 08/11/2021SE |
| K200508 | Pump In StyleHGX · Traditional | 06/15/2020SE |
| K191653 | Freestyle FlexHGX · Traditional | 10/17/2019SE |
Questions and answers
When was Medela Suction Pump cleared by the FDA?
Medela Suction Pump (K830012) received a 510(k) decision of Substantially Equivalent on January 24, 1983, 21 days after the submission was received.
What is the product code of K830012?
The FDA product code is HDB – Extractor, Vacuum, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.4340.