510(k) · Cleared
ClearedBD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson · PHC Infusion Safety Management Software
Cleared on Jun 20, 2025 as substantially equivalent to K182092 (Becton, Dickinson and Company, 2019) after a 266-day review. Its family tree reaches back 8 generations to 1990. 3 of the 13 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 20, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- PHC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904518 (1990). 12 ancestors in all, the oldest K854213 (1985). No later device cites it as a predicate yet. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 7 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 6 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 5 generations backK041241 Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · Recalled (Class I)
- 4 generations backK050883 Safersleep SystemSafer Sleep, LLC · 2005
- 3 generations backK062388 Anesthesia Information and Digital-Drug Management SystemDocusys · 2007
- 2 generations backK141474 Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · Recalled
- 1 generation backK182092 BD Intelliport SystemBecton, Dickinson and Company · 2019
- This deviceK243062 BD Intelliport System; BD Intelliport Reader (516230); BD…Becton Dickinson · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −7 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −6 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −5 | K041241 | Medley System with Bar Code Module, Model 8600 | Alaris Medical Systems, Inc. | 2004 | Class I |
| −4 | K050883 | Safersleep System | Safer Sleep, LLC | 2005 | — |
| −3 | K062388 | Anesthesia Information and Digital-Drug Management System | Docusys | 2007 | — |
| −2 | K141474 | Becton Dickinson Intelliport System | Becton, Dickinson & CO | 2014 | 1 |
| −1 | K182092 | BD Intelliport System | Becton, Dickinson and Company | 2019 | — |
| 0 (this device) | K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor… | Becton Dickinson | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 2003 | 2 | 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.
3 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 PHC device
- #1 K252130 LifeShield Infusion Safety Software Suitescore 12.9 · 7 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 |
|---|---|---|---|
| * | K182092 | BD Intelliport SystemSummary page 5…ar Review Panel General Hospital Predicate Device: Device Trade Name BD Intelliport™ System 510(k) Number K182092 Regulation Number 21 CFR 880.5725 21 CFR 880.5440 Classification Product co… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
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.
- K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 8 companies; a new generation was cleared every 4.4 years on median.
- 5 of the 12 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All PHC devicesPHC Infusion Safety Management Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PHC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHC
Too few PHC 510(k)s in any year since 2007 to give a median.
Recalls per year · PHC
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · PHC
18in 2025
MAUDE reports naming product code PHC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 1 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 2 | — | 1 (1) | 4 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 2 | — | 2 | 18 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BD Intelliport TM System is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients. The BD Intelliport TM System allows the clinician to record anesthesia-related medication administration…
Read the full statement (136 words)
The BD Intelliport TM System is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients.
The BD Intelliport TM System allows the clinician to record anesthesia-related medication administration events during pre-procedure, intra-procedure and recovery phase. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
The BD Intelliport TM System is intended for patients with body weights >20 kg.
Do not use the BD Intelliport TM System with blood, blood products, biologics, or chemotherapeutics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243062: BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243062
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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