FDA product code OTR: Research Use Only/Immunology Devices
OTR is the FDA product code for research use only/immunology devices. It is a Not classified device, reviewed by the Immunology panel. Devices under OTR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OTR devices.
Definition
For research use only and for products imported into the US only.
Classification
| Field | Value |
|---|---|
| Device name | Research Use Only/Immunology Devices |
| Device class | Not classified |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for OTR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-11-03.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- Q4240 — Corecyte, for topical use only, per 0.5 cc
- Q4241 — Polycyte, for topical use only, per 0.5 cc
Frequently asked questions
What is FDA product code OTR?
OTR is the FDA product code for research use only/immunology devices. It is a Not classified device, reviewed by the Immunology panel.
What device class is OTR?
Not classified. Typical premarket route: 510(k) exempt.
Have OTR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code OTR
- Run a recall and safety report across every OTR manufacturer
- Watch product code OTR 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 Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times