FDA product code PHC: Infusion Safety Management Software
PHC is the FDA product code for infusion safety management software. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 10 510(k) submissions under PHC, 7 in the last five years, from 7 different applicants. The average 510(k) review took 290 days (median 268); 305 days on average over the last three years. FDA has posted 13 recalls for PHC devices, 9 initiated in the last five years.
Definition
Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.
Classification
| Field | Value |
|---|---|
| Device name | Infusion Safety Management Software |
| 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 PHC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 270 |
| 2022 | 2 | 458 |
| 2023 | 1 | 265 |
| 2024 | 1 | 385 |
| 2025 | 2 | 262 |
| 2026 | 1 | 269 |
Compare with all 510(k) review times · Search every PHC clearance
Top PHC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Icu Medical, Inc. | 3 | 2026-04-02 |
| Baxter Healthcare Corporation | 2 | 2024-03-29 |
| Becton Dickinson | 1 | 2025-06-20 |
| Fresenius Kabi AG | 1 | 2022-03-01 |
| Becton, Dickinson and Company | 1 | 2019-04-30 |
2 more applicants have PHC clearances. See the full list in Caduvo.
Most recent PHC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252130 | Icu Medical, Inc. | LifeShield Infusion Safety Software Suite | 2026-04-02 | 269 |
| K243062 | Becton Dickinson | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | 2025-06-20 | 266 |
| K242117 | Icu Medical, Inc. | LifeShield Infusion Safety Software Suite | 2025-04-02 | 257 |
| K230665 | Baxter Healthcare Corporation | Dose IQ Safety Software | 2024-03-29 | 385 |
| K223606 | Icu Medical, Inc. | LifeShield Infusion Safety Software Suite | 2023-08-24 | 265 |
Recalls for PHC devices
13 product recalls in 11 recall events; 9 initiated in the last five years and 8 still open. Most recent: 2025-11-24.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2025 | 7 |
Frequently asked questions
What is FDA product code PHC?
PHC is the FDA product code for infusion safety management software. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is PHC?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code PHC?
Across 10 cleared submissions the average was 290 days from receipt to decision (median 268).
Which companies have the most PHC clearances?
Icu Medical, Inc. (3); Baxter Healthcare Corporation (2); Becton Dickinson (1); Fresenius Kabi AG (1); Becton, Dickinson and Company (1).
Have PHC devices been recalled?
Yes: 13 product recalls across 11 recall events; the most recent began 2025-11-24.
Next steps
- Run an FDA pathway report with predicate devices for product code PHC
- Run a recall and safety report across every PHC manufacturer
- Watch product code PHC 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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