510(k) Report

FDA applicant

Xhale, Inc.

Gainesville, FL3 decisions2013–20171 recall

FDA records 3 decisions for Xhale, Inc. (Gainesville, FL) from 2013 to 2017: 3 510(k) clearances. All are in product code DQA (Oximeter). Its devices cite 6 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Xhale”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Xhale, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013: 12015: 12017: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2013high 1 (2019) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Xhale, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xhale, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQAOximeter3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale · 20131cites it
  • K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc. · 20151cites it
  • K171423Nasal Alar SpO2 SensorXhale, Inc. · 20171cites it

What has FDA decided for it lately?

  • K171423Nasal Alar SpO2 SensorXhale, Inc. · 20171 recall
  • K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc. · 20151 recall
  • K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale · 2013

All 2 as Xhale, Inc. →The one decision as Xhale →

What has been recalled?

1 recall linked to its devices; the latest:

  • K143216Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The…May 8, 2019Class II