HFS
12 FDA 510(k) clearances · Product code
77 daysmedian time to decision
186 days90th percentile
12clearances measured
FDA profile
- Official device name
- Shield, Nipple
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5630
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BREAST SHELL (K944177) | O'Donnell, Byrne & Williams | 1994-10-05 |
| AVENT NIPPLE SHIELD (K944117) | Avent America, Inc. | 1994-10-05 |
| COMFORT PLUS NIPPLE SHIELDS (K935340) | Marshall Baby Products | 1994-01-21 |
| COMFORT PLUS BREAST SHELLS (K935341) | Marshall Baby Products | 1994-01-21 |
| BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS (K930238) | Prolac, Inc. | 1993-08-16 |
| BREAST SHELLS (K923577) | Medela, Inc. | 1993-01-22 |
| GENTLE FEEL (K864176) | Mali, Inc. | 1986-11-04 |
| UNICARE BREAST SHELLS (K861608) | Unicare Medical Products, Inc. | 1986-07-15 |
| CANNON BABYSAFE NIPPLE SHIELDS (K853176) | Medela, Inc. | 1985-08-22 |
| ARGYLE ENTERNAL FEEDING BAG W/ADMIN (K840877) | Sherwood Medical Co. | 1984-06-28 |
| NUK BREAST SHIELD (K833450) | Reliance Products Corp. | 1983-11-21 |
| AXICARE BREAST SHELL (K811364) | Neonatal Corp. | 1981-08-03 |
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Every clearance here is in the API, with alerts when new ones post.