FDA product code KSB: Set, Transfer (Blood/Plasma)
KSB is the FDA product code for set, transfer (blood/plasma). It is a Class II device, regulated under 21 CFR 864.9875 and reviewed by the Hematology panel. FDA has cleared 6 510(k) submissions under KSB, from 5 different applicants. The average 510(k) review took 114 days (median 68). FDA has posted 11 recalls for KSB devices.
Classification
| Field | Value |
|---|---|
| Device name | Set, Transfer (Blood/Plasma) |
| Device class | Class II |
| Regulation | 21 CFR 864.9875 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
510(k) clearances per year for KSB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 367 |
Compare with all 510(k) review times · Search every KSB clearance
Top KSB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Venospital, Inc. | 2 | 1979-09-04 |
| Kawasumi Laboratories, Inc. | 1 | 2018-09-28 |
| Kawasumi Laboratories America, Inc. | 1 | 2000-05-19 |
| Alpha Therapeutic Corp. | 1 | 1982-04-14 |
| Geneva Laboratories, Inc. | 1 | 1981-01-15 |
Most recent KSB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172957 | Kawasumi Laboratories, Inc. | Kawasumi Laboratories Blood Drawing Kit (BDK) System | 2018-09-28 | 367 |
| K001043 | Kawasumi Laboratories America, Inc. | KAWASUMI LABORATORY BLOOD DRAWING KIT | 2000-05-19 | 49 |
| K820447 | Alpha Therapeutic Corp. | ALPHA PLASMA TRANSFER SET | 1982-04-14 | 55 |
| K802940 | Geneva Laboratories, Inc. | SUPER-SPIKE TRANSFER SET | 1981-01-15 | 57 |
| K791130 | Venospital, Inc. | FLU-VEN TK-2 | 1979-09-04 | 78 |
Recalls for KSB devices
11 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-07-16.
Frequently asked questions
What is FDA product code KSB?
KSB is the FDA product code for set, transfer (blood/plasma). It is a Class II device, regulated under 21 CFR 864.9875 and reviewed by the Hematology panel.
What device class is KSB?
Class II, regulation 21 CFR 864.9875. Typical premarket route: 510(k).
How long does a 510(k) take for product code KSB?
Across 6 cleared submissions the average was 114 days from receipt to decision (median 68).
Which companies have the most KSB clearances?
Venospital, Inc. (2); Kawasumi Laboratories, Inc. (1); Kawasumi Laboratories America, Inc. (1); Alpha Therapeutic Corp. (1); Geneva Laboratories, Inc. (1).
Have KSB devices been recalled?
Yes: 11 product recalls across 2 recall events; the most recent began 2003-07-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KSB
- Run a recall and safety report across every KSB manufacturer
- Watch product code KSB 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.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times