FDA product code OYI: Non-Bronchoscopic Bronchoalveolar Lavage Catheter
OYI is the FDA product code for non-bronchoscopic bronchoalveolar lavage catheter. It is a Class I device, regulated under 21 CFR 868.6810 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under OYI. The average 510(k) review took 80 days (median 80).
Definition
To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
Classification
| Field | Value |
|---|---|
| Device name | Non-Bronchoscopic Bronchoalveolar Lavage Catheter |
| Device class | Class I |
| Regulation | 21 CFR 868.6810 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OYI clearance
Top OYI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kimberly-Clark | 1 | 2011-12-15 |
Most recent OYI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112562 | Kimberly-Clark | BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER | 2011-12-15 | 80 |
Recalls for OYI devices
openFDA lists no recalls for product code OYI.
Frequently asked questions
What is FDA product code OYI?
OYI is the FDA product code for non-bronchoscopic bronchoalveolar lavage catheter. It is a Class I device, regulated under 21 CFR 868.6810 and reviewed by the Anesthesiology panel.
What device class is OYI?
Class I, regulation 21 CFR 868.6810. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OYI?
Across 1 cleared submissions the average was 80 days from receipt to decision (median 80).
Which companies have the most OYI clearances?
Kimberly-Clark (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OYI
- Run a recall and safety report across every OYI manufacturer
- Watch product code OYI 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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