FDA product code FIN: Tank, Holding, Dialysis
FIN is the FDA product code for tank, holding, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 18 510(k) submissions under FIN, from 15 different applicants. The average 510(k) review took 233 days (median 212). FDA has posted 4 recalls for FIN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tank, Holding, Dialysis |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FIN clearance
Top FIN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tango3, LLC | 2 | 2015-01-12 |
| Ameriwater | 2 | 2014-12-10 |
| Pure Water, Inc. | 2 | 2000-04-10 |
| Isopure, Corp. | 1 | 2012-01-26 |
| Dialysis Services, Inc. | 1 | 2006-09-08 |
10 more applicants have FIN clearances. See the full list in Caduvo.
Most recent FIN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140984 | Tango3, LLC | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM | 2015-01-12 | 271 |
| K141213 | Ameriwater | AMERIWATER OZONE DISINFECTION SYSTEM | 2014-12-10 | 212 |
| K112427 | Isopure, Corp. | BICARB MIXING AND DISTRIBUTION SYSTEM | 2012-01-26 | 156 |
| K093641 | Tango3, LLC | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM | 2010-12-08 | 379 |
| K060333 | Dialysis Services, Inc. | DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM | 2006-09-08 | 211 |
Recalls for FIN devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-04-28.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code FIN?
FIN is the FDA product code for tank, holding, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIN?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIN?
Across 18 cleared submissions the average was 233 days from receipt to decision (median 212).
Which companies have the most FIN clearances?
Tango3, LLC (2); Ameriwater (2); Pure Water, Inc. (2); Isopure, Corp. (1); Dialysis Services, Inc. (1).
Have FIN devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2022-04-28.
Next steps
- Run an FDA pathway report with predicate devices for product code FIN
- Run a recall and safety report across every FIN manufacturer
- Watch product code FIN 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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