ALARIS SYSTEM WITH GUARDRAILS SUITE MX— 510(k) K133532
Substantially EquivalentCarefusion 303, Inc.
FDA 510(k) clearance K133532 for ALARIS SYSTEM WITH GUARDRAILS SUITE MX, Substantially Equivalent on 2014-08-21. Applicant: Carefusion 303, Inc.. Device class: 2.
Clearance details
- Applicant
- Carefusion 303, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Carefusion 303, Inc.
view all- K243855 — BD Alaris Infusion System with Guardrails Suite MX
- K211218 — BD Alaris System with Guardrails Suite MX v12.1.2
- K171957 — MaxZero Extension Sets with Needless Connector
- K163316 — Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
- K110535 — ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K133532
K-number listed on FDA's recall record- Z-1645-2026 — BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Z-0184-2024 — BD Alaris PCU REF 8015
- Z-0185-2024 — BD Alaris Syringe Module, REF 8110
- Z-0186-2024 — Alaris PCA Module 8120
- Z-1544-2021 — Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
- Z-1651-2021 — Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
- Z-1375-2021 — Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
- Z-1309-2021 — BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
- Z-1543-2021 — Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
- Z-1331-2021 — Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
- Z-1332-2021 — Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
- Z-2204-2021 — Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
- Z-2882-2020 — BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
- Z-2909-2020 — Alaris System PC Unit Model 8015
- Z-2910-2020 — PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
- Z-2935-2020 — BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.
- Z-2939-2020 — BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
- Z-2716-2020 — Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
- Z-2717-2020 — Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
- Z-2718-2020 — Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133532.
Data sourced from openFDA. This site is unofficial and independent of the FDA.