Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carefusion 303, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
211 daysmedian FDA review time
819 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | 2025-04-25 | 130 | 0 |
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | 2023-07-21 | 819 | 16 |
| K171957 | MaxZero Extension Sets with Needless Connector | Carefusion 303, Inc. | 2017-07-19 | 20 | 0 |
| K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire Syste | Carefusion 303, Inc. | 2017-06-22 | 211 | 0 |
| K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX | Carefusion 303, Inc. | 2014-08-21 | 276 | 29 |
| K110535 | ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION | Carefusion 303, Inc. | 2012-03-26 | 395 | 0 |
| K110809 | WIRELESS MONITORING SYSTEM | Carefusion 303, Inc. | 2011-07-05 | 104 | 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