PHCClass II
Infusion Safety Management Software
21 CFR 880.5725 / General Hospital
PHC is the FDA product code for Infusion Safety Management Software, a class II device type, regulated under 21 CFR 880.5725. FDA's definition for this code reads: "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...". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 13 recalls.
Classification record
- Product code
- PHC
- Device name
- Infusion Safety Management Software
- FDA 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.
- Regulation
- 21 CFR 880.5725
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 10
- Ingested recalls
- 13
Clearances, product code PHC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2014 | 2 |
| 2019 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code PHC| Applicant | Clearances |
|---|---|
| Abbott Medical | 4 |
| Becton Dickinson & Co | 3 |
| Baxter Healthcare Corporation | 2 |
| Fresenius Kabi AB | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.