Cannon Babysafe Nipple Shields
FDA 510(k) K853176 · Medela, Inc.
510(k) numberK853176
Submission
- Device name
- Cannon Babysafe Nipple Shields
- Applicant
- Medela, Inc.
Crystal Lake, IL, US - Received
- July 12, 1985
- Decision date
- August 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFS – Shield, Nipple
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5630
- Specialty
- General Hospital
Other 510(k)s with product code HFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944177 | Breast ShellHFS · Traditional | O'Donnell, Byrne & Williams | 10/05/1994SE |
| K944117 | Avent Nipple ShieldHFS · Traditional | Avent America, Inc. | 10/05/1994SE |
| K935341 | Comfort Plus Breast ShellsHFS · Traditional | Marshall Baby Products | 01/21/1994SE |
| K935340 | Comfort Plus Nipple ShieldsHFS · Traditional | Marshall Baby Products | 01/21/1994SE |
| K930238 | Breast Leakage Inhibitor System: Breast ShieldsHFS · Traditional | Prolac, Inc. | 08/16/1993SE |
| K923577 | Breast ShellsHFS · Traditional | Medela, Inc. | 01/22/1993SE |
| K864176 | Gentle FeelHFS · Traditional | Mali, Inc. | 11/04/1986SE |
| K861608 | Unicare Breast ShellsHFS · Traditional | Unicare Medical Products, Inc. | 07/15/1986SE |
| K840877 | Argyle Enternal Feeding Bag W/AdminHFS · Traditional | Sherwood Medical Co. | 06/28/1984SE |
| K833450 | Nuk Breast ShieldHFS · Traditional | Reliance Products Corp. | 11/21/1983SE |
More from Reliance Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K253510 | Freestyle Mini Hands-freeHGX · Traditional | 04/10/2026SE |
| K253149 | Motion InBra (YM-8801) wearable breast pumpHGX · Traditional | 02/13/2026SE |
| K253498 | Pump In Style® Pro+HGX · Special | 01/22/2026SE |
| K251377 | Magic InBraHGX · Traditional | 09/18/2025SE |
| K232608 | Duo Hands-free Breast PumpHGX · Special | 04/12/2024SE |
| K223388 | Invia® Integrated DressingOMP · Traditional | 07/07/2023SE |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | 07/26/2022SE |
| K210759 | Solo, Swing MaxiHGX · Traditional | 08/11/2021SE |
| K200508 | Pump In StyleHGX · Traditional | 06/15/2020SE |
| K191653 | Freestyle FlexHGX · Traditional | 10/17/2019SE |
Questions and answers
When was Cannon Babysafe Nipple Shields cleared by the FDA?
Cannon Babysafe Nipple Shields (K853176) received a 510(k) decision of Substantially Equivalent on August 22, 1985, 41 days after the submission was received.
What is the product code of K853176?
The FDA product code is HFS – Shield, Nipple, a Class I (low risk) device regulated under 21 CFR 880.5630.