HFS · Shield, Nipple
General Hospital · 21 CFR 880.5630 · Class 1
Overview
| Product Code | HFS |
|---|---|
| Device Name | Shield, Nipple |
| Regulation | 21 CFR 880.5630 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944177 | BREAST SHELL | O'Donnell, Byrne & Williams | Oct 5, 1994 | SESE |
| K944117 | AVENT NIPPLE SHIELD | Avent America, Inc. | Oct 5, 1994 | SESE |
| K935341 | COMFORT PLUS BREAST SHELLS | Marshall Baby Products | Jan 21, 1994 | SESE |
| K935340 | COMFORT PLUS NIPPLE SHIELDS | Marshall Baby Products | Jan 21, 1994 | SESE |
| K930238 | BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS | Prolac, Inc. | Aug 16, 1993 | SESE |
| K923577 | BREAST SHELLS | Medela, Inc. | Jan 22, 1993 | SESE |
| K864176 | GENTLE FEEL | Mali, Inc. | Nov 4, 1986 | SESE |
| K861608 | UNICARE BREAST SHELLS | Unicare Medical Products, Inc. | Jul 15, 1986 | SESE |
| K853176 | CANNON BABYSAFE NIPPLE SHIELDS | Medela, Inc. | Aug 22, 1985 | SESE |
| K840877 | ARGYLE ENTERNAL FEEDING BAG W/ADMIN | Sherwood Medical Co. | Jun 28, 1984 | SESE |
| K833450 | NUK BREAST SHIELD | Reliance Products Corp. | Nov 21, 1983 | SESE |
| K811364 | AXICARE BREAST SHELL | Neonatal Corp. | Aug 3, 1981 | SESE |
Top Applicants
- Marshall Baby Products — 2 clearances
- Medela, Inc. — 2 clearances
- Avent America, Inc. — 1 clearance
- Mali, Inc. — 1 clearance
- Neonatal Corp. — 1 clearance
