Medibeacon, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Medibeacon, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SDK | Transdermal Test For Assessment Of Glomerular Filtration Rate | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230019 | PMA | MediBeacon® Transdermal GFR Measurement System (TGFR) | 2025-01-17 |
Recalls
openFDA lists no recalls under a recalling firm named Medibeacon, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Medibeacon, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07080008: Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries (Recruiting, started 2026-01-30)
- NCT05777174: Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring (Completed, started 2023-03-20)
- NCT05425719: Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects (Completed, started 2022-06-14)
- NCT03810833: Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System (Completed, started 2019-09-16)
- NCT02772276: Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types (Completed, started 2016-05-11)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medibeacon, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Medibeacon, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Medibeacon, Inc.?
The most frequent FDA product codes under this applicant name are SDK (Transdermal Test For Assessment Of Glomerular Filtration Rate, 1).
Next steps
- See all 0 Medibeacon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SDK, Medibeacon, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.