510(k) · Cleared

Cleared

Sensititre 18-24 Hour Susceptibility Plate

K031545510(k) TraditionalCleared Jul 16, 200361-day reviewClass II21 CFR 866.1640

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

Trek Diagnostic Systems, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems

Cleared on Jul 16, 2003 after a 61-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Jul 16, 2003
Review: 61 days
Class: Class II
Product code: JWY
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK031545 Sensititre 18-24 Hour Susceptibility PlateTrek Diagnostic Systems, Inc. · 2003
Descendant · cites it directly · 1 of its ownK033458 BD Phoenix Automated Microbiology System - Confirmatory Esbl TestBecton, Dickinson & CO · 2004 · Recalled
Descendant · 2 generations on · 0 of its ownK181665 BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNBecton, Dickinson and Company · 2018 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K033458BD Phoenix Automated Microbiology System - Confirmatory Esbl TestBecton, Dickinson & CO · 2004 · cites it directly1descendant
K181665BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNBecton, Dickinson and Company · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K031545	Sensititre 18-24 Hour Susceptibility Plate	Trek Diagnostic Systems, Inc.	2003	—
+1	K033458	BD Phoenix Automated Microbiology System - Confirmatory Esbl Test	Becton, Dickinson & CO	2004	1
+2	K181665	BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN	Becton, Dickinson and Company	2018	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2018	1	0

FIG. 1 — Lineage of K031545, 2003–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JWY? 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 JWY device

#1 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K033458	BD Phoenix Automated Microbiology System - Confirmatory Esbl Test	Becton, Dickinson & CO	2004	1

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?

Of its descendants, K033458 (Becton, Dickinson & CO, 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JWY devices

JWY Manual Antimicrobial Susceptibility Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWY

14in 2025

2007high 18 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWY

106in 2025

2007high 266 (2021) · low 51 (2018)2026

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

Recalls per year · JWY

31in 2022

2007high 31 (2022) · low 0 (2007)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · JWY

1in 2024

2007high 41 (2021) · low 0 (2007)2025

MAUDE reports naming product code JWY, 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	6	85	1	1
2009	2	—	0	1
2010	4	73	0	0
2011	4	125	3	0
2012	1	—	0	0
2013	0	—	0	0
2014	6	106	5	4
2015	9	90	6 (4)	11
2016	4	88	0	20
2017	14	61	2	9
2018	12	51	0	13
2019	18	60	0	10
2020	5	66	0	20
2021	5	266	0	41
2022	0	—	31 (9)	11
2023	7	85	0	9
2024	6	90	0	1
2025	14	106	0	0
2026	2	—	0	—

What is it indicated for?

The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL's in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. Test results can be read either manually or automatically on a Sensititre@ ARIS or Autoreader.

This 510(K) is for ESBL Confirmatory Test Plate for Klebsiella meumoniae, Klebsiella oxvtoca, and Escherichia coli containing the following antimicrobials as per the NCCLS reference standard (M7):

Ceftazimdime: 0.06-128

Ceftazidime/clavulanic acid: 0.06/4-128/4

Cefotaxime: 0.06-64

Cefotaxime/clavulanic acid: 0.06/4-64/4

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K031545 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031545: Sensititre 18-24 Hour Susceptibility Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031545

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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