FDA product code FLB: Meter, Conductivity, Induction, Remote Type
FLB is the FDA product code for meter, conductivity, induction, remote type. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under FLB, from 5 different applicants. The average 510(k) review took 118 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Meter, Conductivity, Induction, Remote Type |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FLB clearance
Top FLB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mesa Medical, Inc. | 2 | 1994-01-25 |
| Myron L Company | 1 | 2010-04-23 |
| Cobe Laboratories, Inc. | 1 | 1983-04-06 |
| Western Laboratories Corp. | 1 | 1982-05-27 |
| Renal Systems, Inc. | 1 | 1977-02-18 |
Most recent FLB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100237 | Myron L Company | DIALYSATE METER, MODEL D-6 | 2010-04-23 | 87 |
| K925210 | Mesa Medical, Inc. | 90DX MULTITEST METER, MODIFICATION | 1994-01-25 | 475 |
| K882032 | Mesa Medical, Inc. | MODEL 90DX MULTITEST METER | 1988-08-11 | 87 |
| K830629 | Cobe Laboratories, Inc. | COBE RX METER | 1983-04-06 | 36 |
| K821415 | Western Laboratories Corp. | MODEL 90 BC | 1982-05-27 | 15 |
Recalls for FLB devices
openFDA lists no recalls for product code FLB.
Frequently asked questions
What is FDA product code FLB?
FLB is the FDA product code for meter, conductivity, induction, remote type. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FLB?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FLB?
Across 6 cleared submissions the average was 118 days from receipt to decision (median 62).
Which companies have the most FLB clearances?
Mesa Medical, Inc. (2); Myron L Company (1); Cobe Laboratories, Inc. (1); Western Laboratories Corp. (1); Renal Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FLB
- Run a recall and safety report across every FLB manufacturer
- Watch product code FLB 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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