FDA product code KJH: Apparatus, Perfusion
KJH is the FDA product code for apparatus, perfusion. 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 KJH. The average 510(k) review took 21 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Perfusion |
| 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 KJH clearance
Top KJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Endotronics, Inc. | 3 | 1988-01-12 |
Most recent KJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K875151 | Endotronics, Inc. | ACUSYST-P/3X | 1988-01-12 | 28 |
| K872086 | Endotronics, Inc. | ACUSYST-JR | 1987-06-15 | 14 |
| K864334 | Endotronics, Inc. | ACUSYST-P (CELL CULTURE EQUIPMENT) | 1986-11-24 | 20 |
Recalls for KJH devices
openFDA lists no recalls for product code KJH.
Frequently asked questions
What is FDA product code KJH?
KJH is the FDA product code for apparatus, perfusion. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel.
What device class is KJH?
Class I, regulation 21 CFR 864.2240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJH?
Across 3 cleared submissions the average was 21 days from receipt to decision (median 20).
Which companies have the most KJH clearances?
Endotronics, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code KJH
- Run a recall and safety report across every KJH manufacturer
- Watch product code KJH 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 Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times