FDA product code PMS: Peripheral Intravenous (Piv) Infiltration Monitor
PMS is the FDA product code for peripheral intravenous (piv) infiltration monitor. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under PMS, 2 in the last five years. The average 510(k) review took 119 days (median 98); 98 days on average over the last three years.
Definition
Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
Classification
| Field | Value |
|---|---|
| Device name | Peripheral Intravenous (Piv) Infiltration Monitor |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PMS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 303 |
| 2022 | 1 | 30 |
| 2024 | 1 | 98 |
Compare with all 510(k) review times · Search every PMS clearance
Top PMS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ivwatch, LLC | 5 | 2024-03-15 |
Most recent PMS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233881 | Ivwatch, LLC | ivWatch® Model 400 | 2024-03-15 | 98 |
| K222212 | Ivwatch, LLC | ivWatch Model 400 | 2022-08-24 | 30 |
| K192385 | Ivwatch, LLC | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | 2020-07-02 | 303 |
| K162478 | Ivwatch, LLC | ivWatch | 2016-12-22 | 107 |
| K153605 | Ivwatch, LLC | ivWatch Model 400 | 2016-02-11 | 56 |
Recalls for PMS devices
openFDA lists no recalls for product code PMS.
Frequently asked questions
What is FDA product code PMS?
PMS is the FDA product code for peripheral intravenous (piv) infiltration monitor. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is PMS?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code PMS?
Across 5 cleared submissions the average was 119 days from receipt to decision (median 98).
Which companies have the most PMS clearances?
Ivwatch, LLC (5).
Next steps
- Run an FDA pathway report with predicate devices for product code PMS
- Run a recall and safety report across every PMS manufacturer
- Watch product code PMS 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 General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times