Product code HFS
- Device name
- Shield, Nipple
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5630
- Review panel
- HO
- 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 |
|---|---|---|---|
| K944117 | AVENT NIPPLE SHIELD | Avent America, Inc. | 1994-10-05 |
| K944177 | BREAST SHELL | O'Donnell, Byrne & Williams | 1994-10-05 |
| K935340 | COMFORT PLUS NIPPLE SHIELDS | Marshall Baby Products | 1994-01-21 |
| K935341 | COMFORT PLUS BREAST SHELLS | Marshall Baby Products | 1994-01-21 |
| K930238 | BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS | Prolac, Inc. | 1993-08-16 |
| K923577 | BREAST SHELLS | Medela, Inc. | 1993-01-22 |
| K864176 | GENTLE FEEL | Mali, Inc. | 1986-11-04 |
| K861608 | UNICARE BREAST SHELLS | Unicare Medical Products, Inc. | 1986-07-15 |
| K853176 | CANNON BABYSAFE NIPPLE SHIELDS | Medela, Inc. | 1985-08-22 |
| K840877 | ARGYLE ENTERNAL FEEDING BAG W/ADMIN | Sherwood Medical Co. | 1984-06-28 |
| K833450 | NUK BREAST SHIELD | Reliance Products Corp. | 1983-11-21 |
| K811364 | AXICARE BREAST SHELL | Neonatal Corp. | 1981-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06978707520081 | Paruu | Linhejiacheng (Shenzhen) E-commerce Co., Ltd. | 2026-03-11 |
| 06978707520098 | Paruu | Linhejiacheng (Shenzhen) E-commerce Co., Ltd. | 2026-03-11 |
| 06978707520104 | Paruu | Linhejiacheng (Shenzhen) E-commerce Co., Ltd. | 2026-03-11 |
| 06978707520111 | Paruu | Linhejiacheng (Shenzhen) E-commerce Co., Ltd. | 2026-03-11 |
| 06978707520128 | Paruu | Linhejiacheng (Shenzhen) E-commerce Co., Ltd. | 2026-03-11 |
| 10735282286817 | Munchkin | MUNCHKIN, INC. | 2025-02-12 |
| 00735282286810 | Munchkin | MUNCHKIN, INC. | 2025-02-12 |
| 09420060202083 | BreastFeeding Nipple Shield - Butterfly Shape | THINK GREEN LIMITED | 2024-12-17 |
| 09420060202021 | Silicone Nipple Shields (2pcs) | THINK GREEN LIMITED | 2024-12-17 |
| 09420060202069 | Breastfeeding Nipple Shield - Orthodontic Teat (Triangle Base) | THINK GREEN LIMITED | 2024-12-17 |
| 09420060202076 | Breastfeeding Nipple Shield - Orthodontic Teat (Round Base) | THINK GREEN LIMITED | 2024-12-17 |
| 09420060202052 | Breastfeeding Nipple Shield - Round Base | THINK GREEN LIMITED | 2024-12-16 |
| 09420060202045 | Ultra-Thin Silicone Nipple Shields - M | THINK GREEN LIMITED | 2024-12-16 |
| 09420060202038 | Ultra-Thin Silicone Nipple Shields - L | THINK GREEN LIMITED | 2024-12-16 |
| 00735282281334 | Munchkin | MUNCHKIN, INC. | 2024-11-14 |
| 00735282281358 | Munchkin | MUNCHKIN, INC. | 2024-11-14 |
| 00735282281327 | Munchkin | MUNCHKIN, INC. | 2024-11-14 |
| 00735282281310 | Munchkin | MUNCHKIN, INC. | 2024-11-14 |
| 00735282383991 | Munchkin | MUNCHKIN, INC. | 2024-06-25 |
| 00735282383984 | Munchkin | MUNCHKIN, INC. | 2024-06-25 |
| 00735282383243 | Munchkin | MUNCHKIN, INC. | 2024-06-25 |
| 00735282383236 | Munchkin | MUNCHKIN, INC. | 2024-06-25 |
| 00072239328064 | Dr. Brown's | Dr. Brown's Company | 2024-04-18 |
| 00072239328057 | Dr. Brown's | Dr. Brown's Company | 2024-04-18 |
| 00814079022104 | Tulips Size S | Ardo medical AG | 2023-05-23 |
| 00814079021862 | Tulips Size S | Ardo medical AG | 2023-05-23 |
| 00072239316382 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239316399 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00814079020186 | Tulips Size L | Ardo medical AG | 2018-09-24 |
| 00814079020155 | Tulips Size M | Ardo medical AG | 2018-09-24 |