FDA product code FID: Tubing, Dialysate
FID is the FDA product code for tubing, dialysate. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FID, from 2 different applicants. The average 510(k) review took 107 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Tubing, Dialysate |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FID clearance
Top FID applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Molded Products, Inc. | 2 | 2002-09-23 |
| Norton Performance Plastics Corp. | 1 | 1977-03-16 |
Most recent FID clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022068 | Molded Products, Inc. | TUBING, DIALYSATE (AND CONNECTOR) | 2002-09-23 | 90 |
| K010712 | Molded Products, Inc. | DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES | 2001-09-27 | 202 |
| K770299 | Norton Performance Plastics Corp. | TYGON M-60/TYGON M-70 | 1977-03-16 | 30 |
Recalls for FID devices
openFDA lists no recalls for product code FID.
Frequently asked questions
What is FDA product code FID?
FID is the FDA product code for tubing, dialysate. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FID?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FID?
Across 3 cleared submissions the average was 107 days from receipt to decision (median 90).
Which companies have the most FID clearances?
Molded Products, Inc. (2); Norton Performance Plastics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FID
- Run a recall and safety report across every FID manufacturer
- Watch product code FID 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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