Pump, Breast, Non-Powered
FDA product code HGY · Class I (low risk) · 21 CFR 884.5150 · Obstetrics/Gynecology
27510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Medela AG 3
- Gerber Products Co. 2
- Hollister, Inc. 2
- American Hospital Supply Corp. 2
- Monterey Laboratories, Inc. 1
- Philips Electronics UK Limited 1
- Evenflo Company, Inc. 1
- White River Concepts 1
- Genesis Industries, Inc. 1
- Avent America, Inc. 1
- White River (Tm) 1
- Crystal Medical Products, Inc. 1
- Les Entreprises Bibi, Inc. 1
- Kean-Rody Manufacturer 1
- Huntleigh Technology, Inc. 1
- Eklund & Co. 1
- Terayco Intl., Ltd. 1
- D.J. Colgate Medical, Ltd. 1
- Burditt & Calkins-Siemens-Elema 1
- Lact-Assist, Inc. 1
510(k) clearances
| 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 |
| K902552 | Gerber Precious Care Electric Breast PumpHGY · Traditional | Gerber Products Co. | 09/26/1990SE |
| K850242 | Crystal Manual Breast PumpHGY · Traditional | Crystal Medical Products, Inc. | 02/25/1985SE |
| K844297 | Supplemental Feeding SystemHGY · Traditional | Medela, Inc. | 02/25/1985SE |
| K843544 | The Bibicure Sys Breast TonerHGY · Traditional | Les Entreprises Bibi, Inc. | 01/25/1985SE |
| K840874 | Rody Breast PumpHGY · Traditional | Kean-Rody Manufacturer | 07/23/1984SE |
| K840325 | Infa Complete Breast Pump & Milk StoragHGY · Traditional | Monterey Laboratories, Inc. | 03/05/1984SE |
| K834399 | New Mother's Way-Breast PumpHGY · Traditional | Huntleigh Technology, Inc. | 01/17/1984SE |
| K833835 | Gentle Flow Breast PumpHGY · Traditional | Eklund & Co. | 11/28/1983SE |
| K831929 | Basic Breast PumpHGY · Traditional | Terayco Intl., Ltd. | 09/29/1983SE |
| K832597 | Gerber Precision Care Breast PumpHGY · Traditional | Gerber Products Co. | 09/12/1983SE |
| K823840 | Medela Namual Breast PumpHGY · Traditional | Medela, Inc. | 01/24/1983SE |
| K823461 | Axipump Manual Breast PumpHGY · Traditional | D.J. Colgate Medical, Ltd. | 01/18/1983SE |
| K823591 | Ameda Hand Breast PumpHGY · Traditional | Burditt & Calkins-Siemens-Elema | 12/28/1982SE |
| K822403 | Lact-Assist Breast PumpHGY · Traditional | Lact-Assist, Inc. | 09/21/1982SE |
| K813247 | Kaneson/Comfort Plus Manual Breast PumpHGY · Traditional | Marshall Electronics, Inc. | 12/03/1981SE |
| K810100 | Breast PumpHGY · Traditional | American Hospital Supply Corp. | 02/12/1981SE |
| K760911 | Breast Care KitHGY · Traditional | American Hospital Supply Corp. | 11/11/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1327-2015 Class II | Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging…Devices were not sterilized | Ameda, Inc. | 02/12/2015Terminated |
| Z-1326-2015 Class II | Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with…Devices were not sterilized | Ameda, Inc. | 02/12/2015Terminated |