# Alaris Medical Systems, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 16 (1998–2004): 16 510(k) clearances
- Product codes: FRN (7), MEA (2), DQA (2), FPA (1), OLW (1), CCK (1), LHI (1), DXH (1)
- Predicates its devices cite: 18 (4 its own); citations of its devices by later devices: 33 (4 its own)
- Recalls linked to its devices: 28 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Y: 2 (https://510kreport.com/company/y)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Baxter Corp.: 1 (https://510kreport.com/company/baxter)
- Sabratek Corp.: 1 (https://510kreport.com/company/sabratek)
- Travenol Laboratories, S.A.: 1 (https://510kreport.com/company/travenol-laboratories)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Spegas Industries, Ltd.: 1 (https://510kreport.com/company/spegas-industries)

## Firms that cite its devices most
- B.Braun Medical, Inc.: 5 (https://510kreport.com/company/b-braun-medical)
- Carefusion 303, Inc.: 3 (https://510kreport.com/company/carefusion-303)
- Iradimed Corporation: 2 (https://510kreport.com/company/iradimed)
- Cardinal Health 303,Inc.: 2 (https://510kreport.com/company/cardinal-health-303)
- Smiths Medical MD, Inc.: 2 (https://510kreport.com/company/smiths-medical-md)
- Sigma Intl.: 1 (https://510kreport.com/company/sigma-intl)
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)
- Clinico: 1 (https://510kreport.com/company/clinico)

## Its most-cited devices
- K030459: Medley System with Medication Management System (MMS) (2003), cited by 9
- K012383: Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C (2001), cited by 4
- K013087: Single Dose Dispensing Pin, Model 2201 (2001), cited by 4
- K023264: Medley Syringe Pump Module System, Model 8110 (2002), cited by 4
- K032233: Medley Pca Module, Model 8120 (2003), cited by 3
- K041241: Medley System with Bar Code Module, Model 8600 (2004), cited by 2

## Recent decisions
- K043299: Medley Pca Module, Model 8120 (Dec 10, 2004)
- K041241: Medley System with Bar Code Module, Model 8600 (Jul 6, 2004)
- K031741: Medley ETCO2 Module (Includes Accessories), Model 8300 (Feb 9, 2004)
- K032233: Medley Pca Module, Model 8120 (Sep 9, 2003)
- K032147: Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series (Jul 25, 2003)
- K030459: Medley System with Medication Management System (MMS) (Apr 4, 2003)
- K023264: Medley Syringe Pump Module System, Model 8110 (Dec 19, 2002)
- K022677: Medley SPO2 Module, Model 8210 & SPO2 Sensors & Cable (Sep 11, 2002)

Source page: https://510kreport.com/company/alaris-medical-systems