FDA product code · Anesthesiology

Mechanical Ventilator

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

ONZClass II21 CFR 868.5895510(k) required6 decisions since 20090 recalls

6 FDA decisions since 2009. No recall names this code. The most-cited predicate is K131562, named by 1 later device.

This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an…

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, anesthesiology panel

Twenty years of ONZ 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 · ONZ

1in 2016

2007high 2 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ONZ

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

Recalls per year · ONZ

No recall names ONZ since 2007.

Adverse event reports per year · ONZ

1in 2020

2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code ONZ, 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	1	—	0
2010	2	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	1
2015	0	—	0
2016	1	—	0
2017	0	—	1
2018	0	—	0
2019	0	—	0
2020	0	—	1
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in ONZ? 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 868.5895.

SGR Noninvasive Positive Airway Pressure System…NQY Ventilator, Continuous, Minimal Ventilatory…MNS Ventilator, Continuous, Non-Life-Supporting MOD Accessory To Continuous Ventilator (Respirator)CBK Ventilator, Continuous, Facility Use MNT Continuous, Minimal Ventilatory Support…NOU Continuous, Ventilator, Home Use

Mechanical Ventilator

Which predicates do ONZ devices cite most?

Which ONZ devices have the deepest lineage?

What has FDA decided in ONZ lately?

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