Apparatus, Hemoperfusion, Sorbent
The Sorbent Hemoperfusion Apparatus is a device used to remove toxins or drugs from a patient's blood by passing it through a column of sorbent material outside the body. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FLD, regulated under 21 CFR 876.5870 in the Gastroenterology and Urology specialty.
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Basic Information
- Product Code
- FLD
- Device Class
- FDA class 2
- Regulation Number
- 876.5870
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT | Mar 26, 2014 | Substantially Equivalent | Gambro Renal Products, Inc. |
| K113313 | MOLECULAR ADSORBENT RECIRCULATING(MARS) | Dec 14, 2012 | Substantially Equivalent | Gambro Renal Products, Inc. |
| K033262 | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) | May 27, 2005 | Substantially Equivalent | Gambro Renal Products |
| K992196 | BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) | Sep 10, 1999 | Substantially Equivalent | Hemocleanse, Inc. |
| K984546 | BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK | Aug 13, 1999 | Substantially Equivalent | Hemocleanse, Inc. |
| K971015 | AHCS HEMOPERFUSION SYSTEM | Oct 22, 1997 | Substantially Equivalent | American Health Care Systems, Inc. |
| K953751 | BIOLOGIC-DT SYSTEM | Feb 15, 1996 | Substantially Equivalent | Hemocleanse, Inc. |
| K885017 | HEMOSORBA CH-500, CH-350 AND CH-180 | Mar 17, 1989 | Substantially Equivalent | Asahi Medical Co., Ltd. |
| K873643 | GAMBRO ADSORBA 150C | Dec 29, 1987 | Substantially Equivalent | Gambro, Inc. |
| K840532 | HEMOPERFUSION SYSTEM TP-400 | May 30, 1984 | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. |
| K831029 | HEMOPERFUSION SYSTEM TP-400 | Aug 26, 1983 | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.