FDA product code · Anesthesiology

Pneumotachometer

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

JAXClass II21 CFR 868.2550510(k) exempt8 decisions since 19770 recalls

FDA lists JAX as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 868.9 applies, such as a new intended use or a different fundamental technology. 8 FDA decisions since 1977. No recall names this code.

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 JAX 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 · JAX

FDA has decided no JAX device since 2007.

Median 510(k) review, days · JAX

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

Recalls per year · JAX

No recall names JAX since 2007.

Adverse event reports per year · JAX

1in 2010

2007high 1 (2010) · low 0 (2007)2025

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

View these four charts as a table

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

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

Planning a device in JAX? 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

Pneumotachometer

What has FDA decided in JAX lately?