FDA product code FKB: Connector, Blood Tubing, Infusion T
FKB is the FDA product code for connector, blood tubing, infusion t. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FKB, from 2 different applicants. The average 510(k) review took 78 days (median 78). FDA has posted 1 recall for FKB devices.
Classification
| Field | Value |
|---|---|
| Device name | Connector, Blood Tubing, Infusion T |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FKB clearance
Top FKB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Akcess Medical Products, Inc. | 1 | 1989-04-07 |
| Quinton, Inc. | 1 | 1977-12-20 |
Most recent FKB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891754 | Akcess Medical Products, Inc. | DC-4 SHUNT INFUSION T | 1989-04-07 | 15 |
| K771426 | Quinton, Inc. | PEDIATRIC INFUSION T | 1977-12-20 | 141 |
Recalls for FKB devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-12-20.
Frequently asked questions
What is FDA product code FKB?
FKB is the FDA product code for connector, blood tubing, infusion t. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKB?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKB?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most FKB clearances?
Akcess Medical Products, Inc. (1); Quinton, Inc. (1).
Have FKB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code FKB
- Run a recall and safety report across every FKB manufacturer
- Watch product code FKB 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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