Shield, Nipple
The Nipple Shield is a thin cover worn over the nipple and areola during breastfeeding to protect sore or cracked nipples, assist in latching for infants with difficulty, or reduce nipple pain during nursing. It is classified as FDA Class 1 (lowest risk) within the General Hospital specialty, subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HFS, regulated under 21 CFR 880.5630. No special risk flags apply.
Basic Information
- Product Code
- HFS
- Device Class
- FDA class 1
- Regulation Number
- 880.5630
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944177 | BREAST SHELL | Oct 05, 1994 | Substantially Equivalent | O'DONNELL, BYRNE & WILLIAMS |
| K944117 | AVENT NIPPLE SHIELD | Oct 05, 1994 | Substantially Equivalent | AVENT AMERICA, INC. |
| K935341 | COMFORT PLUS BREAST SHELLS | Jan 21, 1994 | Substantially Equivalent | MARSHALL BABY PRODUCTS |
| K935340 | COMFORT PLUS NIPPLE SHIELDS | Jan 21, 1994 | Substantially Equivalent | MARSHALL BABY PRODUCTS |
| K930238 | BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS | Aug 16, 1993 | Substantially Equivalent | PROLAC, INC. |
| K923577 | BREAST SHELLS | Jan 22, 1993 | Substantially Equivalent | MEDELA, INC. |
| K864176 | GENTLE FEEL | Nov 04, 1986 | Substantially Equivalent | MALI, INC. |
| K861608 | UNICARE BREAST SHELLS | Jul 15, 1986 | Substantially Equivalent | UNICARE MEDICAL PRODUCTS, INC. |
| K853176 | CANNON BABYSAFE NIPPLE SHIELDS | Aug 22, 1985 | Substantially Equivalent | MEDELA, INC. |
| K840877 | ARGYLE ENTERNAL FEEDING BAG W/ADMIN | Jun 28, 1984 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K833450 | NUK BREAST SHIELD | Nov 21, 1983 | Substantially Equivalent | RELIANCE PRODUCTS CORP. |
| K811364 | AXICARE BREAST SHELL | Aug 03, 1981 | Substantially Equivalent | NEONATAL CORP. |
FEI Numbers
This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 54 registration numbers. Click on an entry to view related FDA registrations.