FDA product code LIF: Dialyzer Reprocessing System
LIF is the FDA product code for dialyzer reprocessing system. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 57 510(k) submissions under LIF, from 30 different applicants. The average 510(k) review took 192 days (median 116). FDA has posted 1 recall for LIF devices.
Classification
| Field | Value |
|---|---|
| Device name | Dialyzer Reprocessing System |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LIF clearance
Top LIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Seratronics, Inc. | 9 | 1996-10-21 |
| Renal Systems, Inc. | 6 | 1984-07-06 |
| Serim Research Corp. | 5 | 1992-04-09 |
| Colorado Medical, Inc. | 4 | 1987-04-10 |
| Minntech Corp. | 3 | 2004-04-27 |
25 more applicants have LIF clearances. See the full list in Caduvo.
Most recent LIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091360 | Novaflux Technologies | CLEARFLUX DIALYZER REPROCESSING SYSTEM | 2010-11-03 | 544 |
| K043126 | Alcavis International, Inc. | ASSIST HEADER CLEANER | 2005-02-03 | 83 |
| K040660 | Hach Company | STERICHEK GLUTARALDEHYDE REAGENT STRIPS | 2004-11-15 | 248 |
| K033505 | Minntech Corp. | RENACLEAN SH DIALYZER CLEANING SYSTEM | 2004-04-27 | 174 |
| K024076 | Hdc Maquinolas, LLC | MAKY 21.1 DIALYZER REPROCESSING SYSTEM | 2003-09-26 | 290 |
Recalls for LIF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-04-21.
Frequently asked questions
What is FDA product code LIF?
LIF is the FDA product code for dialyzer reprocessing system. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is LIF?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIF?
Across 57 cleared submissions the average was 192 days from receipt to decision (median 116).
Which companies have the most LIF clearances?
Seratronics, Inc. (9); Renal Systems, Inc. (6); Serim Research Corp. (5); Colorado Medical, Inc. (4); Minntech Corp. (3).
Have LIF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code LIF
- Run a recall and safety report across every LIF manufacturer
- Watch product code LIF 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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