FDA product code FIE: Needle, Fistula
FIE is the FDA product code for needle, fistula. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 80 510(k) submissions under FIE, 3 in the last five years, from 41 different applicants. The average 510(k) review took 122 days (median 84); 179 days on average over the last three years. FDA has posted 7 recalls for FIE devices.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Fistula |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for FIE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 262 |
| 2018 | 1 | 359 |
| 2022 | 1 | 200 |
| 2025 | 1 | 58 |
| 2026 | 1 | 300 |
Compare with all 510(k) review times · Search every FIE clearance
Top FIE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jms Co., Ltd. | 12 | 2001-09-06 |
| JMS North America Corporation | 6 | 2025-08-15 |
| Medisystems Corp. | 6 | 2007-02-12 |
| Sorensen Research | 6 | 1977-08-16 |
| Nipro Medical Corp. | 5 | 2010-01-22 |
36 more applicants have FIE clearances. See the full list in Caduvo.
Most recent FIE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253469 | Mozarc Medical Us, LLC | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | 2026-08-06 | 300 |
| K251877 | JMS North America Corporation | JMS CAVEO A.V. Fistula Needle Set | 2025-08-15 | 58 |
| K213015 | Bain Medical Equipment (Guangzhou) Co., Ltd. | DORA Disposable A.V. Fistula Needle Sets | 2022-04-08 | 200 |
| K171505 | Dimesol, Inc. | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) | 2018-05-17 | 359 |
| K163025 | Bain Medical Equipment (Guangzhou) Co., Ltd. | DORA Disposable A.V. Fistula Needle Sets | 2017-07-20 | 262 |
Recalls for FIE devices
7 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-12-20.
Frequently asked questions
What is FDA product code FIE?
FIE is the FDA product code for needle, fistula. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is FIE?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIE?
Across 80 cleared submissions the average was 122 days from receipt to decision (median 84).
Which companies have the most FIE clearances?
Jms Co., Ltd. (12); JMS North America Corporation (6); Medisystems Corp. (6); Sorensen Research (6); Nipro Medical Corp. (5).
Have FIE devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2012-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code FIE
- Run a recall and safety report across every FIE manufacturer
- Watch product code FIE 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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