Supplemental Feeding System
FDA 510(k) K844297 · Medela, Inc.
510(k) numberK844297
Submission
- Device name
- Supplemental Feeding System
- Applicant
- Medela, Inc.
Crystal Lake, IL, US - Received
- October 29, 1984
- Decision date
- February 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HGY – Pump, Breast, Non-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5150
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101538 | Handheld Manual Breast Pump (Avent Manual Breast Pump)HGY · Traditional | Philips Electronics UK Limited | 11/05/2010SE |
| K032845 | Easy Comfort Deluxe Manual Breast Pump, Model 1187HGY · Traditional | The First Years, Inc. | 04/05/2004SE |
| K013226 | Evenflo Comfort Ease Manual Breast Pump KitHGY · Traditional | Evenflo Company, Inc. | 12/20/2001SE |
| K011519 | Ameda HygienikitHGY · Traditional | Hollister, Inc. | 08/15/2001SE |
| K971231 | White River Mini Manual Breast PumpHGY · Traditional | White River Concepts | 05/19/1997SE |
| K962828 | Evert-ItHGY · Traditional | Genesis Industries, Inc. | 02/10/1997SE |
| K952034 | Medela's Foot PumpHGY · Traditional | Medela, Inc. | 09/12/1995SE |
| K952035 | NipletteHGY · Traditional | Avent America, Inc. | 07/28/1995SE |
| K925738 | White River Manual Breast PumpHGY · Traditional | White River (Tm) | 05/04/1994SE |
| K912355 | Mothers Touch One Hand Breast PumpHGY · Traditional | Hollister, Inc. | 12/10/1993SE |
More from Hollister, 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 Supplemental Feeding System cleared by the FDA?
Supplemental Feeding System (K844297) received a 510(k) decision of Substantially Equivalent on February 25, 1985, 119 days after the submission was received.
What is the product code of K844297?
The FDA product code is HGY – Pump, Breast, Non-Powered, a Class I (low risk) device regulated under 21 CFR 884.5150.