FDA product code · General hospital
Infusion Safety Management Software
10 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 326 days (half between 265 and 406). 4 recalls name this code, 1 of them Class I. The most-cited predicate is K242117, named by 1 later device.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PHC at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PHC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHC
Too few PHC 510(k)s in any year since 2007 to give a median.
Recalls per year · PHC
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · PHC
18in 2025
MAUDE reports naming product code PHC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 1 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 2 | — | 1 (1) | 4 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 2 | — | 2 | 18 |
| 2026 | 1 | — | 0 | — |
Planning a device in PHC? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 880.5725.