FDA product code KJB: Apparatus, Roller
KJB is the FDA product code for apparatus, roller. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under KJB, from 3 different applicants. The average 510(k) review took 20 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Roller |
| Device class | Class I |
| Regulation | 21 CFR 864.2240 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KJB clearance
Top KJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cryodyne Technologies, Inc. | 1 | 1988-04-18 |
| Corning Medical & Scientific | 1 | 1987-06-15 |
| Solohill Engineering, Inc. | 1 | 1985-07-12 |
Most recent KJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881466 | Cryodyne Technologies, Inc. | CELL-CULTURE SHAKER | 1988-04-18 | 12 |
| K872076 | Corning Medical & Scientific | CORNING DISPOSABLE ROLLER BOTTLES | 1987-06-15 | 17 |
| K852506 | Solohill Engineering, Inc. | BIOGLAS MICROCARRIER BEAD | 1985-07-12 | 30 |
Recalls for KJB devices
openFDA lists no recalls for product code KJB.
Frequently asked questions
What is FDA product code KJB?
KJB is the FDA product code for apparatus, roller. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel.
What device class is KJB?
Class I, regulation 21 CFR 864.2240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJB?
Across 3 cleared submissions the average was 20 days from receipt to decision (median 17).
Which companies have the most KJB clearances?
Cryodyne Technologies, Inc. (1); Corning Medical & Scientific (1); Solohill Engineering, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KJB
- Run a recall and safety report across every KJB manufacturer
- Watch product code KJB 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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