510(k) · Cleared
Recalled · Class I · 2026Alaris System with Guardrails Suite MX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 303, Inc. · FRN Pump, Infusion
Cleared on Aug 21, 2014 as substantially equivalent to K051641 (Cardinal Health, Alaris Products, 2005) and 6 other predicates after a 276-day review. Its family tree reaches back 3 generations to 1994. 7 of the 20 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 35 times, including 28 Class I recalls.
- Decided
- Aug 21, 2014
- Review
- 276 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 35 (28 Class I)
- Predicates
- 7
Its longest line of descent runs back 3 generations to K940147 (1994). 16 ancestors in all, the oldest K890120 (1989). 3 later devices descend from it, 2 citing it directly. 7 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK940147 Auto Syringe AS40A Infusion PumpBaxter Corp. · 1994 · Recalled
- 2 generations backK974332 Variable Pressure Syringe PumpAlaris Medical Systems, Inc. · 1998
- 1 generation backK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- This deviceK133532 Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK211218 BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK243855 BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK210074 Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia…Fresenius Kabi AG · 2022
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · cites it directly1descendant
- K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc. · 2025 · 2 generations on0descendants
- K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…Fresenius Kabi AG · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940147 | Auto Syringe AS40A Infusion Pump | Baxter Corp. | 1994 | 1 |
| −2 | K974332 | Variable Pressure Syringe Pump | Alaris Medical Systems, Inc. | 1998 | — |
| −1 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| 0 (this device) | K133532 | Alaris System with Guardrails Suite MX | Carefusion 303, Inc. | 2014 | — |
| +1 | K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | 2023 | Class I |
| +2 | K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | 2025 | — |
| +1 | K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link… | Fresenius Kabi AG | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 2 | 1 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 1 |
| 2003 | 1 | 0 |
| 2005 | 1 | 1 |
| 2007 | 1 | 1 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
7 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051641 | Alaris System PC Unit, Model 8001Summary page 4…umber Number Code, Regulation Alaris System Components Point-of-Care (PC) Unit Module 8015 80F--RN K051641* K091308 Large Volume Pump (LVP) Module 8100 21 CFR 880.5725 K950419* K012383… | 2005 |
| * | K091308 | Alaris PC Unit, Models 8000 and 8015Summary page 4…Number Code, Regulation Alaris System Components Point-of-Care (PC) Unit Module 8015 80F--RN K051641* K091308 Large Volume Pump (LVP) Module 8100 21 CFR 880.5725 K950419* K012383 Syringe Pump (SYR) Module… | 2009 |
| * | K950419 | The Imed Orion Infusion Pump and Administration SetsSummary page 4…-of-Care (PC) Unit Module 8015 80F--RN K051641* K091308 Large Volume Pump (LVP) Module 8100 21 CFR 880.5725 K950419* K012383 Syringe Pump (SYR) Module 8110 K023264 N/A Guar… | 1995 |
| * | K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii…Summary page 4…8015 80F--RN K051641* K091308 Large Volume Pump (LVP) Module 8100 21 CFR 880.5725 K950419* K012383 Syringe Pump (SYR) Module 8110 K023264 N/A Guardrails Suite MX Component… | 2001 |
| * | K023264 | Medley Syringe Pump Module System, Model 8110Summary page 4…Volume Pump (LVP) Module 8100 21 CFR 880.5725 K950419* K012383 Syringe Pump (SYR) Module 8110 K023264 N/A Guardrails Suite MX Components Alaris Guardrails Editor (GRE) 8961 80F--RN K07210… | 2002 |
| * | K072105 | Alaris System with MMS, Model 8XXXSummary page 4…8110 K023264 N/A Guardrails Suite MX Components Alaris Guardrails Editor (GRE) 8961 80F--RN K072105* K030459 safety software 21 CFR 880.5725 *Primary… | 2007 |
| * | K030459 | Medley System with Medication Management System (MMS)Summary page 4…K023264 N/A Guardrails Suite MX Components Alaris Guardrails Editor (GRE) 8961 80F--RN K072105* K030459 safety software 21 CFR 880.5725 *Primary… | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2026 | Class II | Z-1645-2026 | Under Investigation by firm | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units |
| Sep 15, 2023 | Class I | Z-0185-2024 | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| Sep 15, 2023 | Class I | Z-0184-2024 | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| Sep 15, 2023 | Class I | Z-0186-2024 | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| Mar 26, 2021 | Class I | Z-1544-2021 | Component design/selection | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may… |
| Mar 25, 2021 | Class I | Z-1651-2021 | Under Investigation by firm | Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free… |
| Mar 24, 2021 | Class I | Z-1375-2021 | Component design/selection | Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more… |
| Mar 3, 2021 | Class I | Z-1309-2021 | Process design | Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in… |
| Feb 26, 2021 | Class I | Z-1543-2021 | Component design/selection | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may… |
| Feb 25, 2021 | Class I | Z-2204-2021 | Component design/selection | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may… |
| Feb 25, 2021 | Class I | Z-1331-2021 | Component design/selection | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may… |
| Feb 25, 2021 | Class I | Z-1332-2021 | Component design/selection | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may… |
| Aug 4, 2020 | Class I | Z-2939-2020 | Device Design | Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious… |
| Aug 4, 2020 | Class I | Z-2909-2020 | Reprocessing Controls | The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk… |
| Aug 4, 2020 | Class I | Z-2910-2020 | Reprocessing Controls | The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk… |
| Aug 4, 2020 | Class I | Z-2882-2020 | Component design/selection | The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion. |
| Aug 4, 2020 | Class II | Z-2935-2020 | Vendor change control | Infusion pump component defect may result in interruption of patient monitoring |
| Jun 30, 2020 | Class I | Z-2717-2020 | Device Design | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an… |
| Jun 30, 2020 | Class I | Z-2716-2020 | Device Design | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an… |
| Jun 30, 2020 | Class I | Z-2722-2020 | Device Design | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an… |
| Jun 30, 2020 | Class I | Z-2736-2020 | Device Design | Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane… |
| Jun 30, 2020 | Class I | Z-2741-2020 | Nonconforming Material/Component | If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power… |
| Jun 30, 2020 | Class I | Z-2740-2020 | Nonconforming Material/Component | If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power… |
| Jun 30, 2020 | Class I | Z-2721-2020 | Device Design | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an… |
| Jun 30, 2020 | Class I | Z-2720-2020 | Device Design | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an… |
| Jun 30, 2020 | Class I | Z-2718-2020 | Device Design | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an… |
| Jun 30, 2020 | Class I | Z-2719-2020 | Device Design | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an… |
| Jun 30, 2020 | Class I | Z-2723-2020 | Device Design | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an… |
| Jun 30, 2020 | Class II | Z-2822-2020 | Device Design | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. |
| Jun 30, 2020 | Class II | Z-2824-2020 | Device Design | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. |
| Jun 30, 2020 | Class II | Z-2823-2020 | Device Design | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. |
| Jun 30, 2020 | Class II | Z-2825-2020 | Device Design | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. |
| Jun 30, 2020 | Class II | Z-2826-2020 | Device Design | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. |
| Feb 4, 2020 | Class I | Z-1359-2020 | Device Design | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion… |
| Apr 13, 2018 | Class I | Z-1768-2019 | Component design/selection | The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e.… |
The 5 latest of 35 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K072105Alaris System with MMS, Model 8XXXCardinal Health 303,Inc. · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 13 Class I recalls
- K051641Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 110 Class I recalls
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii)…Alaris Medical Systems, Inc. · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 13 Class I recalls
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · Direct predicate · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 17 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 10 of the 16 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K211218 (Carefusion 303, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K051641.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Alaris System with Guardrails Suite MX is intended for use in professional healthcare facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products. The Alaris System with Guardrails Suite MX is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and…
Read the full statement (137 words)
The Alaris System with Guardrails Suite MX is intended for use in professional healthcare facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.
The Alaris System with Guardrails Suite MX is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
The Alaris System with Guardrails Suite MX is an interoperable system capable of communicating and exchanging data accurately, effectively, securely, and consistently with different information technology systems, sooftware applications, and networks, in various settings; and exchanging data such that the clinical or operational purpose and meaning of the data are preserved and unaltered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133532: Alaris System with Guardrails Suite MX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133532
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026