Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alaris Medical Systems, Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
288 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043299 | MEDLEY PCA MODULE, MODEL 8120 | Alaris Medical Systems, Inc. | 2004-12-10 | 10 | 3 |
| K041241 | MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 | Alaris Medical Systems, Inc. | 2004-07-06 | 56 | 2 |
| K031741 | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 | Alaris Medical Systems, Inc. | 2004-02-09 | 250 | 1 |
| K032233 | MEDLEY PCA MODULE, MODEL 8120 | Alaris Medical Systems, Inc. | 2003-09-09 | 50 | 2 |
| K032147 | SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTR | Alaris Medical Systems, Inc. | 2003-07-25 | 11 | 1 |
| K030459 | MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) | Alaris Medical Systems, Inc. | 2003-04-04 | 52 | 0 |
| K023264 | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 | Alaris Medical Systems, Inc. | 2002-12-19 | 80 | 5 |
| K022677 | MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE | Alaris Medical Systems, Inc. | 2002-09-11 | 30 | 2 |
| K022209 | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS | Alaris Medical Systems, Inc. | 2002-08-06 | 29 | 7 |
| K013087 | SINGLE DOSE DISPENSING PIN, MODEL 2201 | Alaris Medical Systems, Inc. | 2001-11-13 | 57 | 0 |
| K012383 | GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PU | Alaris Medical Systems, Inc. | 2001-10-02 | 67 | 12 |
| K010965 | A-LINE AEP MONITOR | Alaris Medical Systems, Inc. | 2001-06-27 | 86 | 0 |
| K010966 | MEDLEY SP02 MODULE, MODEL 8220 | Alaris Medical Systems, Inc. | 2001-06-08 | 67 | 2 |
| K993524 | ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS | Alaris Medical Systems, Inc. | 2000-08-01 | 288 | 0 |
| K983626 | KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II | Alaris Medical Systems, Inc. | 1999-02-05 | 113 | 0 |
| K974332 | VARIABLE PRESSURE SYRINGE PUMP | Alaris Medical Systems, Inc. | 1998-12-29 | 406 | 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