Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA

Gastric Emptying Breath Test

PMA Number: P110015 · 2026-04-24

ApplicantAdvanced Breath Diagnostics
Decision Date2026-04-24
PMA NumberP110015
Product CodePGE
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCH

Device Summary

Gastric Emptying Breath Test is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Breath Diagnostics. It received FDA 510(k) clearance on 2026-04-24. The device is classified under product code PGE. It was reviewed by the CH advisory panel.

Frequently Asked Questions

What is the Gastric Emptying Breath Test?

Gastric Emptying Breath Test is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Advanced Breath Diagnostics.

When did Gastric Emptying Breath Test receive FDA 510(k) clearance?

The clearance date for Gastric Emptying Breath Test can be found in the official FDA records.

Who is the listed applicant for Gastric Emptying Breath Test?

The FDA 510(k) record lists Advanced Breath Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gastric Emptying Breath Test?

The FDA product code for Gastric Emptying Breath Test is PGE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑