FDA product code KIO: Slide Stainer, Immersion Type
KIO is the FDA product code for slide stainer, immersion type. It is a Class I device, regulated under 21 CFR 864.3800 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under KIO. The average 510(k) review took 36 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Slide Stainer, Immersion Type |
| Device class | Class I |
| Regulation | 21 CFR 864.3800 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIO clearance
Top KIO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shandon, Inc. | 1 | 1989-04-04 |
Most recent KIO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890984 | Shandon, Inc. | LINISTAIN SLS | 1989-04-04 | 36 |
Recalls for KIO devices
openFDA lists no recalls for product code KIO.
Frequently asked questions
What is FDA product code KIO?
KIO is the FDA product code for slide stainer, immersion type. It is a Class I device, regulated under 21 CFR 864.3800 and reviewed by the Pathology panel.
What device class is KIO?
Class I, regulation 21 CFR 864.3800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIO?
Across 1 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most KIO clearances?
Shandon, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KIO
- Run a recall and safety report across every KIO manufacturer
- Watch product code KIO 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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