FDA product code LBW: Set, Dialysis, Single Needle (Co-Axial Flow)
LBW is the FDA product code for set, dialysis, single needle (co-axial flow). It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under LBW, from 4 different applicants. The average 510(k) review took 31 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Set, Dialysis, Single Needle (Co-Axial Flow) |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LBW clearance
Top LBW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quinton, Inc. | 2 | 1986-12-16 |
| Akcess Medical Products, Inc. | 1 | 1990-11-23 |
| Terumo Medical Corp. | 1 | 1982-04-16 |
| Medical Components, Inc. | 1 | 1980-09-26 |
Most recent LBW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904433 | Akcess Medical Products, Inc. | DUAL LUMEN NEEDLES | 1990-11-23 | 56 |
| K864629 | Quinton, Inc. | MODIFIED DUAL LUMEN NEEDLE | 1986-12-16 | 21 |
| K860515 | Quinton, Inc. | DUAL LUMEN NEEDLE (PRODUCT CHANGE) | 1986-03-04 | 21 |
| K820859 | Terumo Medical Corp. | COAXIAL DUAL FLOW CATHETER | 1982-04-16 | 18 |
| K801968 | Medical Components, Inc. | HEMOCATH I KIDNEY DIALYSIS CATHETER | 1980-09-26 | 38 |
Recalls for LBW devices
openFDA lists no recalls for product code LBW.
Frequently asked questions
What is FDA product code LBW?
LBW is the FDA product code for set, dialysis, single needle (co-axial flow). It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is LBW?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBW?
Across 5 cleared submissions the average was 31 days from receipt to decision (median 21).
Which companies have the most LBW clearances?
Quinton, Inc. (2); Akcess Medical Products, Inc. (1); Terumo Medical Corp. (1); Medical Components, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LBW
- Run a recall and safety report across every LBW manufacturer
- Watch product code LBW 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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