FDA product code IYT: System, Rebreathing, Radionuclide
IYT is the FDA product code for system, rebreathing, radionuclide. It is a Class II device, regulated under 21 CFR 892.1390 and reviewed by the Radiology panel. FDA has cleared 48 510(k) submissions under IYT, from 18 different applicants. The average 510(k) review took 88 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | System, Rebreathing, Radionuclide |
| Device class | Class II |
| Regulation | 21 CFR 892.1390 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IYT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 148 |
Top IYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medipart Jerry Alexander | 23 | 1990-02-26 |
| Amici, Inc. | 5 | 1991-01-14 |
| Medi Nuclear Corp., Inc. | 3 | 1987-10-20 |
| Vital Signs, Inc. | 2 | 1991-08-02 |
| Mallinckrodt Critical Care | 2 | 1985-01-14 |
13 more applicants have IYT clearances. See the full list in Caduvo.
Most recent IYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200916 | Cyclomedica Australia Pty, Ltd. | Patient Administration Set | 2020-09-01 | 148 |
| K953513 | King Systems Corp. | XENON CIRCUIT | 1995-11-03 | 100 |
| K952223 | Intertech Resources, Inc. | XENON GAS BREATHING CIRCUIT | 1995-08-11 | 91 |
| K914747 | Gibeck, Inc. | XENON CIRCUIT | 1992-02-27 | 128 |
| K913416 | Tetley Medical , Ltd. | TETLEY PATIENT ADMINISTRATION SET | 1991-10-28 | 89 |
Recalls for IYT devices
openFDA lists no recalls for product code IYT.
Frequently asked questions
What is FDA product code IYT?
IYT is the FDA product code for system, rebreathing, radionuclide. It is a Class II device, regulated under 21 CFR 892.1390 and reviewed by the Radiology panel.
What device class is IYT?
Class II, regulation 21 CFR 892.1390. Typical premarket route: 510(k).
How long does a 510(k) take for product code IYT?
Across 48 cleared submissions the average was 88 days from receipt to decision (median 73).
Which companies have the most IYT clearances?
Medipart Jerry Alexander (23); Amici, Inc. (5); Medi Nuclear Corp., Inc. (3); Vital Signs, Inc. (2); Mallinckrodt Critical Care (2).
Next steps
- Run an FDA pathway report with predicate devices for product code IYT
- Run a recall and safety report across every IYT manufacturer
- Watch product code IYT 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.