Product code HGY
- Device name
- Pump, Breast, Non-Powered
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 1
- Regulation number
- 884.5150
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101538 | HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) | Philips Electronics UK Limited | 2010-11-05 |
| K032845 | EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 | The First Years, Inc. | 2004-04-05 |
| K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | Evenflo Company, Inc. | 2001-12-20 |
| K011519 | AMEDA HYGIENIKIT | Hollister, Inc. | 2001-08-15 |
| K971231 | WHITE RIVER MINI MANUAL BREAST PUMP | White River Concepts | 1997-05-19 |
| K962828 | EVERT-IT | Genesis Industries, Inc. | 1997-02-10 |
| K952034 | MEDELA'S FOOT PUMP | Medela, Inc. | 1995-09-12 |
| K952035 | NIPLETTE | Avent America, Inc. | 1995-07-28 |
| K925738 | WHITE RIVER MANUAL BREAST PUMP | White River (Tm) | 1994-05-04 |
| K912355 | MOTHERS TOUCH ONE HAND BREAST PUMP | Hollister, Inc. | 1993-12-10 |
| K902552 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP | Gerber Products Co. | 1990-09-26 |
| K844297 | SUPPLEMENTAL FEEDING SYSTEM | Medela, Inc. | 1985-02-25 |
| K850242 | CRYSTAL MANUAL BREAST PUMP | Crystal Medical Products, Inc. | 1985-02-25 |
| K843544 | THE BIBICURE SYS BREAST TONER | Les Entreprises Bibi, Inc. | 1985-01-25 |
| K840874 | RODY BREAST PUMP | Kean-Rody Manufacturer | 1984-07-23 |
| K840325 | INFA COMPLETE BREAST PUMP & MILK STORAG | Monterey Laboratories, Inc. | 1984-03-05 |
| K834399 | NEW MOTHER'S WAY-BREAST PUMP | Huntleigh Technology, Inc. | 1984-01-17 |
| K833835 | GENTLE FLOW BREAST PUMP | Eklund & Co. | 1983-11-28 |
| K831929 | BASIC BREAST PUMP | Terayco Intl., Ltd. | 1983-09-29 |
| K832597 | GERBER PRECISION CARE BREAST PUMP | Gerber Products Co. | 1983-09-12 |
| K823840 | MEDELA NAMUAL BREAST PUMP | Medela, Inc. | 1983-01-24 |
| K823461 | AXIPUMP MANUAL BREAST PUMP | D.J. Colgate Medical, Ltd. | 1983-01-18 |
| K823591 | AMEDA HAND BREAST PUMP | Burditt & Calkins-Siemens-Elema | 1982-12-28 |
| K822403 | LACT-ASSIST BREAST PUMP | Lact-Assist, Inc. | 1982-09-21 |
| K813247 | KANESON/COMFORT PLUS MANUAL BREAST PUMP | Marshall Electronics, Inc. | 1981-12-03 |
| K810100 | BREAST PUMP | American Hospital Supply Corp. | 1981-02-12 |
| K760911 | BREAST CARE KIT | American Hospital Supply Corp. | 1976-11-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809108019097 | Spectra | UZINMEDICARE CO.,LTD | 2025-10-15 |
| 09420060201123 | Gen. 1 Silicone Breast Pump & Flower Stopper Set - Blue | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201345 | Gen. 2 Silicone Breast Pump & Cap Set - 100ml - Blush | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201291 | Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - Purple | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201277 | Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - Orange | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201253 | Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - Purple | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201246 | Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - Blue | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201222 | Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - White | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201215 | Gen. 1 Silicone Breast Pump & Flower Stopper Set - Purple | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201208 | Gen. 1 Silicone Breast Pump & Flower Stopper Set - Blue | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201192 | Gen. 1 Silicone Breast Pump & Flower Stopper Set - Orange | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201178 | Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - Orange | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201161 | Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - Purple | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201154 | GBHK023-B-WM Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - Blue | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201147 | Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - Blue | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201130 | Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - White | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201116 | Gen. 1 Silicone Breast Pump & Flower Stopper Set - Purple | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201109 | Gen. 1 Silicone Breast Pump & Flower Stopper Set - White | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201048 | Gen.2 Silicone Breast Pump - 150ml | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201031 | Gen.2 Silicone Breast Pump - 100ml | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201024 | Gen. 1 Silicone Breast Pump | THINK GREEN LIMITED | 2024-12-10 |
| 09420060201017 | A manual, silicone breast pump that uses natural suction to draw out milk from t | THINK GREEN LIMITED | 2024-12-10 |
| 08809108017437 | Spectra | UZINMEDICARE CO.,LTD | 2024-09-09 |
| 00072239316306 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239323724 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239323403 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239319475 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 08809108017550 | Spectra | UZINMEDICARE CO.,LTD | 2019-10-19 |
| 08809224871135 | Unimom | UNIMOM CO. | 2018-12-13 |
| 08809108012760 | Spectra | UZINMEDICARE CO.,LTD | 2017-03-06 |