510(k) Report

FDA product code · Cardiovascular

Adjunctive Hemodynamic Indicator With Decision Point

QNVClass II21 CFR 870.2220510(k) required3 decisions since 20210 recalls

3 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 110 days (half between 94 and 125). No recall names this code. The most-cited predicate is DEN200022, named by 2 later devices.

An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.

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, cardiovascular panel

Twenty years of QNV 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 · QNV

1in 2022

2021: 22022: 1
2007high 2 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QNV

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

Recalls per year · QNV

No recall names QNV since 2007.

Adverse event reports per year · QNV

No MAUDE report names QNV 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
20212—00
20221—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — QNV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QNV? 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 QNV devices cite most?

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

  • DEN200022Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc. · 20212cite it
  • K212219AHI SystemFifth Eye, Inc. · 20211cites it

Which QNV devices have the deepest lineage?

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

  • K221203AHI SystemFifth Eye, Inc. · 202228generations
  • K212219AHI SystemFifth Eye, Inc. · 202127generations

What has FDA decided in QNV lately?

  • K221203AHI SystemFifth Eye, Inc. · 2022
  • K212219AHI SystemFifth Eye, Inc. · 2021
  • DEN200022Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc. · 2021

All 3 QNV decisions →

Related product codes

Other codes under 21 CFR 870.2220.

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