FDA product code FOS: Catheter, Umbilical Artery
FOS is the FDA product code for catheter, umbilical artery. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. FDA has cleared 34 510(k) submissions under FOS, from 19 different applicants. The average 510(k) review took 139 days (median 148). FDA has posted 7 recalls for FOS devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Umbilical Artery |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FOS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 318 |
Compare with all 510(k) review times · Search every FOS clearance
Top FOS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sherwood Medical Co. | 6 | 1995-12-13 |
| Gesco Intl., Inc. | 6 | 1994-08-02 |
| Vygon Corp. | 3 | 1992-10-26 |
| Footprint Medical | 2 | 2009-09-25 |
| Neomed, Inc. | 2 | 2008-07-21 |
14 more applicants have FOS clearances. See the full list in Caduvo.
Most recent FOS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201697 | Haolang Medical USA Corporation | Umbilical Vessels Catheter | 2021-05-06 | 318 |
| K130725 | Covidien Lp, Formerly Registered AS Kendall | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. | 2013-04-17 | 30 |
| K120304 | Footprint Medical, Inc. | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | 2012-03-01 | 29 |
| K091214 | Footprint Medical | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | 2009-09-25 | 151 |
| K091213 | Footprint Medical | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | 2009-09-25 | 151 |
Recalls for FOS devices
7 product recalls in 2 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2025-05-02.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2025 | 6 |
Frequently asked questions
What is FDA product code FOS?
FOS is the FDA product code for catheter, umbilical artery. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.
What device class is FOS?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code FOS?
Across 34 cleared submissions the average was 139 days from receipt to decision (median 148).
Which companies have the most FOS clearances?
Sherwood Medical Co. (6); Gesco Intl., Inc. (6); Vygon Corp. (3); Footprint Medical (2); Neomed, Inc. (2).
Have FOS devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2025-05-02.
Next steps
- Run an FDA pathway report with predicate devices for product code FOS
- Run a recall and safety report across every FOS manufacturer
- Watch product code FOS 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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