Data / Medical devices / United States / Lucid Diagnostics, Inc.
Lucid Diagnostics, Inc.: FDA-registered device maker in Foxborough, MA, United States, 1 510(k) clearance
Lucid Diagnostics, Inc. is registered with the FDA (registration 3016490370) in Foxborough, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 24, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016490370
- Address
- 200 Foxborough Boulevard Suite 300, Foxborough, MA, United States, 02035
- Owner or operator
- Lucid Diagnostics, Inc. (10062329)
- Roles
- Specification developer
- First device listed
- January 15, 2020
- Registered through
- 2026
- Brand names listed
- EsoCheck, EsoGuard Preservation Solution
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Specification developer | accessdata.fda.gov |
| Esophagoscope (Flexible Or Rigid) | EOX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2023 | K230339 | EsoCheck Cell Collection Device | EOX | Unknown | Lucid Diagnostics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 24, 2024 | 94510 | Class II | Ongoing | Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-b | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal. | accessdata.fda.gov |
Compare with other makers
- All makers of Esophagoscope (Flexible Or Rigid)
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
Updated May 24, 2024. 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.