FDA product code FLD: Apparatus, Hemoperfusion, Sorbent
FLD is the FDA product code for apparatus, hemoperfusion, sorbent. It is a Class II device, regulated under 21 CFR 876.5870 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 11 510(k) submissions under FLD, from 7 different applicants. The average 510(k) review took 208 days (median 149). FDA has posted 7 recalls for FLD devices.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Hemoperfusion, Sorbent |
| Device class | Class II |
| Regulation | 21 CFR 876.5870 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every FLD clearance
Top FLD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hemocleanse, Inc. | 3 | 1999-09-10 |
| Gambro Renal Products, Inc. | 2 | 2014-03-26 |
| Extracorporeal Medical Specialities, Inc. | 2 | 1984-05-30 |
| Gambro Renal Products | 1 | 2005-05-27 |
| American Health Care Systems, Inc. | 1 | 1997-10-22 |
2 more applicants have FLD clearances. See the full list in Caduvo.
Most recent FLD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133807 | Gambro Renal Products, Inc. | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT | 2014-03-26 | 100 |
| K113313 | Gambro Renal Products, Inc. | MOLECULAR ADSORBENT RECIRCULATING(MARS) | 2012-12-14 | 401 |
| K033262 | Gambro Renal Products | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) | 2005-05-27 | 596 |
| K992196 | Hemocleanse, Inc. | BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) | 1999-09-10 | 72 |
| K984546 | Hemocleanse, Inc. | BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK | 1999-08-13 | 234 |
Recalls for FLD devices
7 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-21.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code FLD?
FLD is the FDA product code for apparatus, hemoperfusion, sorbent. It is a Class II device, regulated under 21 CFR 876.5870 and reviewed by the Gastroenterology and Urology panel.
What device class is FLD?
Class II, regulation 21 CFR 876.5870. Typical premarket route: 510(k).
How long does a 510(k) take for product code FLD?
Across 11 cleared submissions the average was 208 days from receipt to decision (median 149).
Which companies have the most FLD clearances?
Hemocleanse, Inc. (3); Gambro Renal Products, Inc. (2); Extracorporeal Medical Specialities, Inc. (2); Gambro Renal Products (1); American Health Care Systems, Inc. (1).
Have FLD devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2017-12-21.
Next steps
- Run an FDA pathway report with predicate devices for product code FLD
- Run a recall and safety report across every FLD manufacturer
- Watch product code FLD 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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