FDA product code FOX: Stand, Infusion
FOX is the FDA product code for stand, infusion. It is a Class I device, regulated under 21 CFR 880.6990 and reviewed by the General Hospital panel. FDA has cleared 36 510(k) submissions under FOX, from 33 different applicants. The average 510(k) review took 67 days (median 43). FDA has posted 5 recalls for FOX devices.
Classification
| Field | Value |
|---|---|
| Device name | Stand, Infusion |
| Device class | Class I |
| Regulation | 21 CFR 880.6990 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FOX clearance
Top FOX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ferguson Medical | 3 | 1988-11-21 |
| E.F. Brewer Co. | 2 | 1985-02-07 |
| Clinton Industries, Inc. | 1 | 1998-04-06 |
| Medrad, Inc. | 1 | 1997-02-25 |
| Prins Medical Ind., Inc. | 1 | 1996-07-22 |
28 more applicants have FOX clearances. See the full list in Caduvo.
Most recent FOX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K980336 | Clinton Industries, Inc. | IV STANDS | 1998-04-06 | 68 |
| K964782 | Medrad, Inc. | MEDRAD CONTRAST HOLDER | 1997-02-25 | 90 |
| K961470 | Prins Medical Ind., Inc. | PORT-A-POLE | 1996-07-22 | 96 |
| K960027 | Allen Medical Systems, Inc. | HIGH VOLUME I.V. & IRRIGATION TOWER | 1996-03-12 | 70 |
| K952196 | Valentine Intl. , Ltd. | IV POLE/STAND | 1995-07-31 | 83 |
Recalls for FOX devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-01.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code FOX?
FOX is the FDA product code for stand, infusion. It is a Class I device, regulated under 21 CFR 880.6990 and reviewed by the General Hospital panel.
What device class is FOX?
Class I, regulation 21 CFR 880.6990. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FOX?
Across 36 cleared submissions the average was 67 days from receipt to decision (median 43).
Which companies have the most FOX clearances?
Ferguson Medical (3); E.F. Brewer Co. (2); Clinton Industries, Inc. (1); Medrad, Inc. (1); Prins Medical Ind., Inc. (1).
Have FOX devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2017-12-01.
Next steps
- Run an FDA pathway report with predicate devices for product code FOX
- Run a recall and safety report across every FOX manufacturer
- Watch product code FOX 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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