510(k) Report

FDA product code · Microbiology

Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

QZXClass II21 CFR 866.1650510(k) required3 decisions since 20240 recalls

3 FDA decisions since 2024. 510(k) reviews decided 2021–2025 took a median of 254 days (half between 171 and 353). No recall names this code. The most-cited predicate is K231536, named by 1 later device.

Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.

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

FIG. A — Illustration, microbiology panel

Twenty years of QZX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QZX

1in 2025

2024: 22025: 1
2007high 2 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QZX

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

Recalls per year · QZX

No recall names QZX since 2007.

Adverse event reports per year · QZX

No MAUDE report names QZX since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20242—00
20251—00
20260—0—
FIG. 1 — QZX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QZX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do QZX devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K231536eQUANT SystemAvails Medical, Inc. · 20241cites it
  • K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 20241cites it

Which QZX devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K244044PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 20254generations
  • K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 20243generations
  • K231536eQUANT SystemAvails Medical, Inc. · 20242generations

What has FDA decided in QZX lately?

  • K244044PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 2025
  • K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 2024
  • K231536eQUANT SystemAvails Medical, Inc. · 2024

All 3 QZX decisions →

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