510(k) · Cleared

Cleared

BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)

K190905510(k) TraditionalCleared Jul 1, 201984-day reviewClass II21 CFR 866.1645

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Becton, Dickinson and Company · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Cleared on Jul 1, 2019 as substantially equivalent to K132909 (Becton, Dickinson and Company, 2014) after an 84-day review. Its family tree reaches back 1 generation to 2014. 1 later device descends from it.

Decided: Jul 1, 2019
Review: 84 days
Class: Class II
Product code: LON
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K132909 (2014). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK132909 BD Phoenix Automated Microbiology System Tigecycline (0.25-16 UG/ML)Becton, Dickinson and Company · 2014
This deviceK190905 BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4…Becton, Dickinson and Company · 2019
Descendant · cites it directly · 0 of its ownK211748 Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc. · 2023

Most influential descendants

Showing 1 of 1 · See all

K211748Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K132909	BD Phoenix Automated Microbiology System Tigecycline (0.25-16 UG/ML)	Becton, Dickinson and Company	2014	—
0 (this device)	K190905	BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)	Becton, Dickinson and Company	2019	—
+1	K211748	Selux AST System; Model AST Gen 1.0	Selux Diagnostics, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K190905, 2014–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in LON? 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 LON device

#1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K132909	BD Phoenix Automated Microbiology System Tigecycline (0.25-16 UG/ML) Summary page 3 …ssification: Class II Review Panel: Microbiology Product Code: LON Predicate Device BD Phoenix™ Automated Microbiology System – GN Tigecycline (0.25-16 μg/mL) [510(k) K132909] Page 1 of 4 BD Phoenix™ A…	Becton, Dickinson and Company	2014	—

Also cleared against K132909: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K211748	Selux AST System; Model AST Gen 1.0	Selux Diagnostics, Inc.	2023	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K211748 (Selux Diagnostics, Inc., 2023) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K132909.

How does its category compare?

All LON devices

LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · LON

5in 2025

2007high 19 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LON

90in 2025

2007high 268 (2021) · low 50 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LON

1in 2025

2007high 116 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LON

690in 2025

2007high 690 (2025) · low 0 (2009)2025

MAUDE reports naming product code LON, 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	19	50	0	3
2008	7	66	1	1
2009	8	76	0	0
2010	1	—	116	3
2011	8	85	3	4
2012	10	200	3	9
2013	7	115	0	3
2014	4	90	2 (2)	10
2015	0	—	0	41
2016	3	242	2	94
2017	10	89	1	197
2018	4	88	6	512
2019	8	84	1	315
2020	5	81	8	218
2021	5	268	0	232
2022	8	189	15	180
2023	11	210	0	453
2024	2	—	1	418
2025	5	90	1	690
2026	4	146	6	—

What is it indicated for?

The BD Phoenix™ Automated Microbiology System is intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and non-Enterobacteriaceae.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190905 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190905: BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190905

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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