Data / Medical devices / United States / Cairn Diagnostics
Cairn Diagnostics: FDA-registered device maker in Brentwood, TN, United States, 1 PMA approval
Cairn Diagnostics is registered with the FDA (registration 3010031043) in Brentwood, TN, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated April 6, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010031043
- FEI number
- 3009091796
- Address
- 105 Westpark DR Ste 150, Brentwood, TN, United States, 37027
- Owner or operator
- Advanced Breath Diagnostics, LLC (10049228)
- Roles
- Manufacturer
- First device listed
- April 30, 2015
- Registered through
- 2026
- Brand names listed
- 13C-Spirulina, 13C-Spirulina GEBT, 13C-Spirulina Gastric Emptying Breath Test (GEBT), Gastric Emptying Breath Test (GEBT)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gastric Emptying Breath Test | PGE | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 6, 2015 | P110015 | GASTRIC EMPTYING BREATH TEST (GEBT) | PGE | 10 | April 24, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 8, 2021 | 87186 | Class II | Terminated | 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) | Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates | accessdata.fda.gov |
Updated April 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.