FDA product code QYU: Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
QYU is the FDA product code for infant pulse rate and oxygen saturation monitor for over-the-counter use. It is a Class II device, regulated under 21 CFR 870.2705 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under QYU, 1 in the last five years. The average 510(k) review took 135 days (median 135); 135 days on average over the last three years. 1 De Novo request was granted under it.
Definition
An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s).
Classification
| Field | Value |
|---|---|
| Device name | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use |
| Device class | Class II |
| Regulation | 21 CFR 870.2705 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QYU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 135 |
Top QYU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Masimo Corporation | 1 | 2024-05-03 |
Most recent QYU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234021 | Masimo Corporation | Masimo Stork | 2024-05-03 | 135 |
Recalls for QYU devices
openFDA lists no recalls for product code QYU.
Frequently asked questions
What is FDA product code QYU?
QYU is the FDA product code for infant pulse rate and oxygen saturation monitor for over-the-counter use. It is a Class II device, regulated under 21 CFR 870.2705 and reviewed by the Cardiovascular panel.
What device class is QYU?
Class II, regulation 21 CFR 870.2705. Typical premarket route: 510(k).
How long does a 510(k) take for product code QYU?
Across 1 cleared submissions the average was 135 days from receipt to decision (median 135).
Which companies have the most QYU clearances?
Masimo Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QYU
- Run a recall and safety report across every QYU manufacturer
- Watch product code QYU 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.