HGY · Pump, Breast, Non-Powered
Obstetrics/Gynecology · 21 CFR 884.5150 · Class 1
Overview
| Product Code | HGY |
|---|---|
| Device Name | Pump, Breast, Non-Powered |
| Regulation | 21 CFR 884.5150 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
Identification
A nonpowered breast pump is a manual suction device used to express milk from the breast.
Classification Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9, if the device is using either a bulb or telescoping mechanism which does not develop more than 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce cytotoxicity, irritation, or sensitization effects.
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K101538 | HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) | Philips Electronics UK Limited | Nov 5, 2010 | SESE |
| K032845 | EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 | The First Years, Inc. | Apr 5, 2004 | SESE |
| K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | Evenflo Company, Inc. | Dec 20, 2001 | SESE |
| K011519 | AMEDA HYGIENIKIT | Hollister, Inc. | Aug 15, 2001 | SESE |
| K971231 | WHITE RIVER MINI MANUAL BREAST PUMP | White River Concepts | May 19, 1997 | SESE |
| K962828 | EVERT-IT | Genesis Industries, Inc. | Feb 10, 1997 | SESE |
| K952034 | MEDELA'S FOOT PUMP | Medela, Inc. | Sep 12, 1995 | SESE |
| K952035 | NIPLETTE | Avent America, Inc. | Jul 28, 1995 | SESE |
| K925738 | WHITE RIVER MANUAL BREAST PUMP | White River (Tm) | May 4, 1994 | SESE |
| K912355 | MOTHERS TOUCH ONE HAND BREAST PUMP | Hollister, Inc. | Dec 10, 1993 | SESE |
| K902552 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP | Gerber Products Co. | Sep 26, 1990 | SESE |
| K850242 | CRYSTAL MANUAL BREAST PUMP | Crystal Medical Products, Inc. | Feb 25, 1985 | SESE |
| K844297 | SUPPLEMENTAL FEEDING SYSTEM | Medela, Inc. | Feb 25, 1985 | SESE |
| K843544 | THE BIBICURE SYS BREAST TONER | Les Entreprises Bibi, Inc. | Jan 25, 1985 | SESE |
| K840874 | RODY BREAST PUMP | Kean-Rody Manufacturer | Jul 23, 1984 | SESE |
| K840325 | INFA COMPLETE BREAST PUMP & MILK STORAG | Monterey Laboratories, Inc. | Mar 5, 1984 | SESE |
| K834399 | NEW MOTHER'S WAY-BREAST PUMP | Huntleigh Technology, Inc. | Jan 17, 1984 | SESE |
| K833835 | GENTLE FLOW BREAST PUMP | Eklund & Co. | Nov 28, 1983 | SESE |
| K831929 | BASIC BREAST PUMP | Terayco Intl., Ltd. | Sep 29, 1983 | SESE |
| K832597 | GERBER PRECISION CARE BREAST PUMP | Gerber Products Co. | Sep 12, 1983 | SESE |
Top Applicants
- Medela, Inc. — 3 clearances
- American Hospital Supply Corp. — 2 clearances
- Gerber Products Co. — 2 clearances
- Hollister, Inc. — 2 clearances
- Avent America, Inc. — 1 clearance
