FDA product code · Cardiovascular

Single Lumen Ecmo Cannula

Name: FDA decisions, review times, recalls and adverse event reports for product code QHW
Creator: 510(k) Report

QHWClass II21 CFR 870.4100510(k) required3 decisions since 20220 recalls

3 FDA decisions since 2022. 510(k) reviews decided 2021–2025 took a median of 343 days (half between 198 and 488). No recall names this code. The most-cited predicate is K201057, named by 2 later devices.

Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

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 QHW 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 · QHW

1in 2024

2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QHW

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

Recalls per year · QHW

No recall names QHW since 2007.

Adverse event reports per year · QHW

7in 2025

2007high 18 (2024) · low 0 (2007)2025

MAUDE reports naming product code QHW, 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	0	—	0
2022	1	—	1
2023	0	—	8
2024	1	—	18
2025	0	—	7
2026	1	—	—

FIG. 1 — QHW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QHW? 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

Related product codes

Other codes under 21 CFR 870.4100.

QWF Tubing, Long Term Support Greater Than 6 Hours QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use BYS Oxygenator, Long Term Support Greater Than 6…PZS Dual Lumen Ecmo Cannula QJZ Extracorporeal System For Long-Term…

Single Lumen Ecmo Cannula

Which predicates do QHW devices cite most?

Which QHW devices have the deepest lineage?

What has FDA decided in QHW lately?

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