Product Code: HGY
FDA class 1
21 CFR 884.5150
Pump, Breast, Non-Powered
Obstetrics/Gynecology
The Non-Powered Breast Pump is a manually operated device used by lactating women to express breast milk through hand- or body-powered suction mechanisms, without an electric motor. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HGY, regulated under 21 CFR 884.5150, within the Obstetrics/Gynecology specialty. No special risk flags apply.
510(k)s
27
FEI Numbers
92
Registration Numbers
92
Unique Applicants
22
Years Active
34
Basic Information
- Product Code
- HGY
- Device Class
- FDA class 1
- Regulation Number
- 884.5150
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 27 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K101538 | HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) | Nov 05, 2010 | Substantially Equivalent | PHILIPS ELECTRONICS UK LIMITED |
| K032845 | EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 | Apr 05, 2004 | Substantially Equivalent | THE FIRST YEARS, INC. |
| K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | Dec 20, 2001 | Substantially Equivalent | EVENFLO COMPANY, INC. |
| K011519 | AMEDA HYGIENIKIT | Aug 15, 2001 | Substantially Equivalent | HOLLISTER, INC. |
| K971231 | WHITE RIVER MINI MANUAL BREAST PUMP | May 19, 1997 | Substantially Equivalent | WHITE RIVER CONCEPTS |
| K962828 | EVERT-IT | Feb 10, 1997 | Substantially Equivalent | GENESIS INDUSTRIES, INC. |
| K952034 | MEDELA'S FOOT PUMP | Sep 12, 1995 | Substantially Equivalent | MEDELA, INC. |
| K952035 | NIPLETTE | Jul 28, 1995 | Substantially Equivalent | AVENT AMERICA, INC. |
| K925738 | WHITE RIVER MANUAL BREAST PUMP | May 04, 1994 | Substantially Equivalent | WHITE RIVER (TM) |
| K912355 | MOTHERS TOUCH ONE HAND BREAST PUMP | Dec 10, 1993 | Substantially Equivalent | HOLLISTER, INC. |
| K902552 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP | Sep 26, 1990 | Substantially Equivalent | GERBER PRODUCTS CO. |
| K850242 | CRYSTAL MANUAL BREAST PUMP | Feb 25, 1985 | Substantially Equivalent | CRYSTAL MEDICAL PRODUCTS, INC. |
| K844297 | SUPPLEMENTAL FEEDING SYSTEM | Feb 25, 1985 | Substantially Equivalent | MEDELA, INC. |
| K843544 | THE BIBICURE SYS BREAST TONER | Jan 25, 1985 | Substantially Equivalent | LES ENTREPRISES BIBI, INC. |
| K840874 | RODY BREAST PUMP | Jul 23, 1984 | Substantially Equivalent | KEAN-RODY MANUFACTURER |
| K840325 | INFA COMPLETE BREAST PUMP & MILK STORAG | Mar 05, 1984 | Substantially Equivalent | MONTEREY LABORATORIES, INC. |
| K834399 | NEW MOTHER'S WAY-BREAST PUMP | Jan 17, 1984 | Substantially Equivalent | HUNTLEIGH TECHNOLOGY, INC. |
| K833835 | GENTLE FLOW BREAST PUMP | Nov 28, 1983 | Substantially Equivalent | EKLUND & CO. |
| K831929 | BASIC BREAST PUMP | Sep 29, 1983 | Substantially Equivalent | TERAYCO INTL., LTD. |
| K832597 | GERBER PRECISION CARE BREAST PUMP | Sep 12, 1983 | Substantially Equivalent | GERBER PRODUCTS CO. |
| K823840 | MEDELA NAMUAL BREAST PUMP | Jan 24, 1983 | Substantially Equivalent | MEDELA, INC. |
| K823461 | AXIPUMP MANUAL BREAST PUMP | Jan 18, 1983 | Substantially Equivalent | D.J. COLGATE MEDICAL, LTD. |
| K823591 | AMEDA HAND BREAST PUMP | Dec 28, 1982 | Substantially Equivalent | BURDITT & CALKINS-SIEMENS-ELEMA |
| K822403 | LACT-ASSIST BREAST PUMP | Sep 21, 1982 | Substantially Equivalent | LACT-ASSIST, INC. |
| K813247 | KANESON/COMFORT PLUS MANUAL BREAST PUMP | Dec 03, 1981 | Substantially Equivalent | MARSHALL ELECTRONICS, INC. |
| K810100 | BREAST PUMP | Feb 12, 1981 | Substantially Equivalent | AMERICAN HOSPITAL SUPPLY CORP. |
| K760911 | BREAST CARE KIT | Nov 11, 1976 | Substantially Equivalent | AMERICAN HOSPITAL SUPPLY CORP. |
FEI Numbers
This FDA classification entry is associated with 92 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 92 registration numbers. Click on an entry to view related FDA registrations.