510(k) · Cleared

Cleared

BD Kiestra IdentifA

K191964510(k) TraditionalCleared Nov 3, 2021834-day reviewClass II21 CFR 866.3378

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 · QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Cleared on Nov 3, 2021 as substantially equivalent to DEN170081 (Bruker Daltonik GmbH, 2018) after an 834-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.

Decided: Nov 3, 2021
Review: 834 days
Class: Class II
Product code: QQV
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN170081 (2018). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN170081 MALDI Biotyper CA SystemBruker Daltonik GmbH · 2018
This deviceK191964 BD Kiestra IdentifABecton, Dickinson and Company · 2021
Descendant · cites it directly · 0 of its ownK222563 BD Kiestra IdentifABecton, Dickinson and Company · 2023

Most influential descendants

Showing 1 of 1 · See all

K222563BD Kiestra IdentifABecton, Dickinson and Company · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN170081	MALDI Biotyper CA System	Bruker Daltonik GmbH	2018	—
0 (this device)	K191964	BD Kiestra IdentifA	Becton, Dickinson and Company	2021	—
+1	K222563	BD Kiestra IdentifA	Becton, Dickinson and Company	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K191964, 2018–2023Source: 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 QQV? 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 QQV device

#1 K223245 Colibríscore 9.8 · 7 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
*	DEN170081	MALDI Biotyper CA System Summary page 14 …alence studies demonstrate that specimen and MALDI target preparation on the BD Kiestra™ IdentifA is substantially equivalent to the predicate, Bruker MALDI Biotyper CA, DEN 170081 April 20, 2018.	Bruker Daltonik GmbH	2018	—

Also cleared against DEN170081: 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
K222563	BD Kiestra IdentifA	Becton, Dickinson and Company	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, K222563 (Becton, Dickinson and Company, 2023) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate DEN170081.

How does its category compare?

All QQV devices

QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · QQV

2in 2023

2007high 2 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QQV

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

Recalls per year · QQV

No recall names QQV since 2007.

Adverse event reports per year · QQV

1in 2024

2007high 1 (2024) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	2	—	0
2022	0	—	0
2023	2	—	0
2024	0	—	1
2025	0	—	0
2026	0	—	—

What is it indicated for?

The BD Kiestra IdentifA module is an automated in vitro diagnostic specimen preparation system for use with the BD Kiestra Laboratory Automation Solution to prepare MALDI targets for the Bruker MALDI Biotyper CA System for the qualitative identification and differentiation of microorganisms using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis of colonies grown on plated culture media from human specimens.

The BD Kiestra IdentifA is indicated for use in the clinical laboratory with the BD Kiestra ReadA Compact and Bruker MALDI Biotyper CA System to aid in the diagnosis of bacterial and fungal infections.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K191964 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191964: BD Kiestra IdentifA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191964

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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