510(k) · Cleared
ClearedBD Intelliport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · PHC Infusion Safety Management Software
Cleared on Apr 30, 2019 as substantially equivalent to K141474 (Becton, Dickinson & CO, 2014) after a 270-day review. Its family tree reaches back 7 generations to 1990. 3 of the 13 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Apr 30, 2019
- Review
- 270 days
- Class
- Class II
- Product code
- PHC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904518 (1990). 11 ancestors in all, the oldest K854213 (1985). 1 later device descends from it, 1 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 6 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 5 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 4 generations backK041241 Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · Recalled (Class I)
- 3 generations backK050883 Safersleep SystemSafer Sleep, LLC · 2005
- 2 generations backK062388 Anesthesia Information and Digital-Drug Management SystemDocusys · 2007
- 1 generation backK141474 Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · Recalled
- This deviceK182092 BD Intelliport SystemBecton, Dickinson and Company · 2019
- Descendant · cites it directly · 0 of its ownK243062 BD Intelliport System; BD Intelliport Reader (516230); BD…Becton Dickinson · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K243062BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)…Becton Dickinson · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −6 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −5 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −4 | K041241 | Medley System with Bar Code Module, Model 8600 | Alaris Medical Systems, Inc. | 2004 | Class I |
| −3 | K050883 | Safersleep System | Safer Sleep, LLC | 2005 | — |
| −2 | K062388 | Anesthesia Information and Digital-Drug Management System | Docusys | 2007 | — |
| −1 | K141474 | Becton Dickinson Intelliport System | Becton, Dickinson & CO | 2014 | 1 |
| 0 (this device) | K182092 | BD Intelliport System | Becton, Dickinson and Company | 2019 | — |
| +1 | 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 |
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.
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 |
|---|---|---|---|
| * | K141474 | Becton Dickinson Intelliport SystemSummary page 4…ation of substantial equivalence of the BD Intelliport Medication Management System, Version 1.2, to the cited predicate device (the BD Intelliport System, cleared under K141474). ‘% BD 1 Becton Drive Franklin Lakes, NJ 07417 w Tel: 201.847.6800 bd.com 2 Submission Administrative Detail… | 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 |
|---|---|---|---|
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)… | 2025 | 0 |
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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 11 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K243062 (Becton Dickinson, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PHC devicesPHC Infusion Safety Management Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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™ 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™ system allows the clinician to record anesthesia-related, medication administration…
Read the full statement (148 words)
The BD Intelliport™ 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™ system allows the clinician to record anesthesia-related, medication administration events in the pre-op, intra-op, and PACU. 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™ system is intended for patients whose body weights are >20kg.
The BD Intelliport™ system is not intended for use with blood, blood products, biologics, or chemotherapeutics.
The BD Intelliport™ system is not intended for use with refrigerated medications (excluding cefazolin).
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/K182092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182092: BD Intelliport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182092
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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