FDA product code FPD: Tube, Feeding
FPD is the FDA product code for tube, feeding. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 59 510(k) submissions under FPD, 1 in the last five years, from 43 different applicants. The average 510(k) review took 167 days (median 123); 51 days on average over the last three years. FDA has posted 24 recalls for FPD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Feeding |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for FPD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 354 |
| 2024 | 1 | 51 |
Compare with all 510(k) review times · Search every FPD clearance
Top FPD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sandoz Nutrition | 6 | 1993-03-12 |
| Vygon Corp. | 4 | 2012-12-18 |
| Corpak Medsystems | 4 | 2009-03-05 |
| Philips Medical Systems | 2 | 2013-10-23 |
| Boston Scientific Corp | 2 | 2009-06-09 |
38 more applicants have FPD clearances. See the full list in Caduvo.
Most recent FPD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243361 | Vygon USA | Nutrifit | 2024-12-19 | 51 |
| K180236 | Vr Medical Technology Co., Ltd. | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | 2019-01-18 | 354 |
| K131590 | Philips Medical Systems | INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE | 2013-10-23 | 145 |
| K120815 | Philips Medical Systems | INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE | 2013-03-06 | 352 |
| K121105 | Vygon Corp. | NUTRISAFE 2 FEEDING TUBE | 2012-12-18 | 250 |
Recalls for FPD devices
24 product recalls in 14 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2022-08-01.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 8 |
| 2019 | 3 |
| 2020 | 7 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code FPD?
FPD is the FDA product code for tube, feeding. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is FPD?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code FPD?
Across 59 cleared submissions the average was 167 days from receipt to decision (median 123).
Which companies have the most FPD clearances?
Sandoz Nutrition (6); Vygon Corp. (4); Corpak Medsystems (4); Philips Medical Systems (2); Boston Scientific Corp (2).
Have FPD devices been recalled?
Yes: 24 product recalls across 14 recall events; the most recent began 2022-08-01.
Next steps
- Run an FDA pathway report with predicate devices for product code FPD
- Run a recall and safety report across every FPD manufacturer
- Watch product code FPD 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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