FDA product code FIL: System, Dialysate Delivery, Single Pass
FIL is the FDA product code for system, dialysate delivery, single pass. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 8 510(k) submissions under FIL, from 7 different applicants. The average 510(k) review took 99 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | System, Dialysate Delivery, Single Pass |
| 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 FIL clearance
Top FIL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Travenol Laboratories, S.A. | 2 | 1977-11-30 |
| Hemametrics | 1 | 2002-07-23 |
| Baxter Healthcare Corp | 1 | 1990-04-19 |
| Fresenius USA, Inc. | 1 | 1989-05-11 |
| Cyberex Corp. | 1 | 1979-06-27 |
2 more applicants have FIL clearances. See the full list in Caduvo.
Most recent FIL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011741 | Hemametrics | CRIT-LINE MONITOR III TQA (CLM TQA) | 2002-07-23 | 413 |
| K901038 | Baxter Healthcare Corp | SPS 550-IPS (INTEGRATED PATIENT STATION) | 1990-04-19 | 44 |
| K890329 | Fresenius USA, Inc. | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM | 1989-05-11 | 108 |
| K790824 | Cyberex Corp. | REPGREEN ULTRAFILTRATION MONITOR | 1979-06-27 | 57 |
| K781633 | Extracorporeal Medical Specialities, Inc. | ULTRAFILTRATION SCALE | 1978-12-07 | 77 |
Recalls for FIL devices
openFDA lists no recalls for product code FIL.
Frequently asked questions
What is FDA product code FIL?
FIL is the FDA product code for system, dialysate delivery, single pass. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIL?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIL?
Across 8 cleared submissions the average was 99 days from receipt to decision (median 56).
Which companies have the most FIL clearances?
Travenol Laboratories, S.A. (2); Hemametrics (1); Baxter Healthcare Corp (1); Fresenius USA, Inc. (1); Cyberex Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FIL
- Run a recall and safety report across every FIL manufacturer
- Watch product code FIL 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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