Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PHC — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
269 daysmedian FDA review time
502 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2026-04-02 | 269 | 0 |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD In | Becton Dickinson | 2025-06-20 | 266 | 0 |
| K242117 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2025-04-02 | 257 | 2 |
| K230665 | Dose IQ Safety Software | Baxter Healthcare Corporation | 2024-03-29 | 385 | 0 |
| K223606 | LifeShield™ Infusion Safety Software Suite | Icu Medical, Inc. | 2023-08-24 | 265 | 1 |
| K211124 | Dose IQ Safety Software | Baxter Healthcare Corporation | 2022-08-30 | 502 | 0 |
| K210075 | Vigilant Software Suite – Vigilant Master Med | Fresenius Kabi AG | 2022-03-01 | 413 | 0 |
| K182092 | BD Intelliport System | Becton, Dickinson and Company | 2019-04-30 | 270 | 0 |
| K141474 | BECTON DICKINSON INTELLIPORT SYSTEM | Becton, Dickinson & CO | 2014-12-18 | 198 | 1 |
| K141193 | MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHA | Smiths Medical Asd, Inc. | 2014-07-25 | 78 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda