510(k) · Cleared
Recalled · Class I · 2026BD Alaris System with Guardrails Suite MX v12.1.2
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 Jul 21, 2023 as substantially equivalent to K133532 (Carefusion 303, Inc., 2014) after an 819-day review. Its family tree reaches back 4 generations to 1994. 7 of the 19 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 16 times, including 7 Class I recalls.
- Decided
- Jul 21, 2023
- Review
- 819 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 16 (7 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940147 (1994). 17 ancestors in all, the oldest K890120 (1989). 1 later device descends from it, 1 citing it directly. 7 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK940147 Auto Syringe AS40A Infusion PumpBaxter Corp. · 1994 · Recalled
- 3 generations backK974332 Variable Pressure Syringe PumpAlaris Medical Systems, Inc. · 1998
- 2 generations backK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- 1 generation backK133532 Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Recalled (Class I)
- This deviceK211218 BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK243855 BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc. · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940147 | Auto Syringe AS40A Infusion Pump | Baxter Corp. | 1994 | 1 |
| −3 | K974332 | Variable Pressure Syringe Pump | Alaris Medical Systems, Inc. | 1998 | — |
| −2 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| −1 | K133532 | Alaris System with Guardrails Suite MX | Carefusion 303, Inc. | 2014 | Class I |
| 0 (this device) | K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | 2023 | — |
| +1 | K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | 2025 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K133532 | Alaris System with Guardrails Suite MXSummary page 7…1 Predicate Device The predicate device is the Alaris System with Guardrails Suite MX cleared under K133532 (August 21, 2014). Device Description The BD Alaris System with Guardrails Suite MX v12 is a modular infusion and monitoring sys… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | 2025 | 0 |
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 |
| Nov 6, 2025 | Class II | Z-1217-2026 | Under Investigation by firm | Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices… |
| Oct 17, 2025 | Class I | Z-0430-2026 | Device Design | If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed… |
| Jul 8, 2025 | Class I | Z-2179-2025 | Under Investigation by firm | Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. |
| Feb 18, 2025 | Class I | Z-1304-2025 | Under Investigation by firm | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| Feb 18, 2025 | Class I | Z-1305-2025 | Under Investigation by firm | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| Jan 23, 2025 | Class II | Z-1231-2025 | Under Investigation by firm | Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is… |
| Aug 15, 2024 | Class II | Z-3139-2024 | Process control | Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| Aug 15, 2024 | Class II | Z-3138-2024 | Process control | Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| Aug 15, 2024 | Class II | Z-3140-2024 | Process control | Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| Aug 15, 2024 | Class II | Z-3141-2024 | Process control | Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| Aug 15, 2024 | Class II | Z-3142-2024 | Process control | Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| May 21, 2024 | Class II | Z-2262-2024 | Under Investigation by firm | Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server. |
| 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. |
The 5 latest of 16 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.
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Direct predicate · ◆ on the line of descent in FIG. 128 Class I recalls
- K072105Alaris System with MMS, Model 8XXXCardinal Health 303,Inc. · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 13 Class I recalls
- K051641Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 110 Class I recalls
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 2 generations back · ◆ 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 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 13 Class I recalls
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 2 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 11 of the 17 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K243855 (Carefusion 303, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133532.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. See Pediatric*, Neonate**, and Adult Patient Population Tables for the module-specific variations. Administered…
Read the full statement (179 words)
The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. See Pediatric*, Neonate**, and Adult Patient Population Tables for the module-specific variations. Administered fluids include pharmaceutical drugs, red blood cells, and other blood components (platelets and fresh frozen plasma) as required for patient therapy. The BD Alaris System is an interoperable system capable of communicating and exchanging data with compatible information technology systems.
The BD Alaris System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, End-Tidal CO2 (EtCO2) Module, Auto-ID Module, Patient-Controlled Analgesia (PCA) Module, and associated software applications. The EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
The BD Alaris Pump Module, Syringe Module, and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211218: BD Alaris System with Guardrails Suite MX v12.1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211218
Report an extraction error
Are you the manufacturer?
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