510(k) · Cleared

Cleared

Bactec Pyrazinamide Susceptibility Test

K895362510(k) TraditionalCleared Dec 1, 198994-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

Bd Becton Dickinson Vacutainer Systems Preanalytic · JTT Susceptibility Test Powders, Antimicrobial

Cleared on Dec 1, 1989 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Dec 1, 1989
Review: 94 days
Class: Class II
Product code: JTT
Recalls: None
Predicates: 0

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

This deviceK895362 Bactec Pyrazinamide Susceptibility TestBd Becton Dickinson Vacutainer Systems Preanalytic · 1989
Descendant · cites it directly · 0 of its ownK052323 Versatrek Myco Pza KitTrek Diagnostic Systems, Inc. · 2006
Descendant · cites it directly · 0 of its ownK021582 Bactec Mgit 960 Pza KitBecton, Dickinson & CO · 2002 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K052323Versatrek Myco Pza KitTrek Diagnostic Systems, Inc. · 2006 · cites it directly0descendants
K021582Bactec Mgit 960 Pza KitBecton, Dickinson & CO · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K895362	Bactec Pyrazinamide Susceptibility Test	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989	—
+1	K052323	Versatrek Myco Pza Kit	Trek Diagnostic Systems, Inc.	2006	—
+1	K021582	Bactec Mgit 960 Pza Kit	Becton, Dickinson & CO	2002	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2006	1	0

FIG. 1 — Lineage of K895362, 1989–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in JTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052323	Versatrek Myco Pza Kit	Trek Diagnostic Systems, Inc.	2006	0
K021582	Bactec Mgit 960 Pza Kit	Becton, Dickinson & CO	2002	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?

Of its descendants, K052323 (Trek Diagnostic Systems, Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JTT devices

JTT Susceptibility Test Powders, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JTT

FDA has decided no JTT device since 2007.

Median 510(k) review, days · JTT

Too few JTT 510(k)s in any year since 2007 to give a median.

Recalls per year · JTT

No recall names JTT since 2007.

Adverse event reports per year · JTT

2in 2017

2007high 2 (2017) · low 0 (2007)2025

MAUDE reports naming product code JTT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	2
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K895362 · printed Nov 4, 2026

Cite this page

510(k) Report. “K895362: Bactec Pyrazinamide Susceptibility Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895362

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026