FDA product code HFS: Shield, Nipple
HFS is the FDA product code for shield, nipple. It is a Class I device, regulated under 21 CFR 880.5630 and reviewed by the General Hospital panel. FDA has cleared 12 510(k) submissions under HFS, from 10 different applicants. The average 510(k) review took 84 days (median 77). FDA has posted 1 recall for HFS devices.
Classification
| Field | Value |
|---|---|
| Device name | Shield, Nipple |
| Device class | Class I |
| Regulation | 21 CFR 880.5630 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HFS clearance
Top HFS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marshall Baby Products | 2 | 1994-01-21 |
| Medela, Inc. | 2 | 1993-01-22 |
| Avent America, Inc. | 1 | 1994-10-05 |
| O'Donnell, Byrne & Williams | 1 | 1994-10-05 |
| Prolac, Inc. | 1 | 1993-08-16 |
5 more applicants have HFS clearances. See the full list in Caduvo.
Most recent HFS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944117 | Avent America, Inc. | AVENT NIPPLE SHIELD | 1994-10-05 | 43 |
| K944177 | O'Donnell, Byrne & Williams | BREAST SHELL | 1994-10-05 | 40 |
| K935341 | Marshall Baby Products | COMFORT PLUS BREAST SHELLS | 1994-01-21 | 77 |
| K935340 | Marshall Baby Products | COMFORT PLUS NIPPLE SHIELDS | 1994-01-21 | 77 |
| K930238 | Prolac, Inc. | BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS | 1993-08-16 | 209 |
Recalls for HFS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-05-18.
Frequently asked questions
What is FDA product code HFS?
HFS is the FDA product code for shield, nipple. It is a Class I device, regulated under 21 CFR 880.5630 and reviewed by the General Hospital panel.
What device class is HFS?
Class I, regulation 21 CFR 880.5630. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HFS?
Across 12 cleared submissions the average was 84 days from receipt to decision (median 77).
Which companies have the most HFS clearances?
Marshall Baby Products (2); Medela, Inc. (2); Avent America, Inc. (1); O'Donnell, Byrne & Williams (1); Prolac, Inc. (1).
Have HFS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code HFS
- Run a recall and safety report across every HFS manufacturer
- Watch product code HFS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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