Infinite Biomedical Technologies, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Infinite Biomedical Technologies, LLC” (first 2008, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 97 days. Since 2017 the median was 60 days, against 145 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 90 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 14 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Infinite Biomedical Technologies, LLC took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 3 | 3 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 2 | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
Review panels
- Neurology (6)
Most recent Infinite Biomedical Technologies, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240884 | Glide (91000-GL-X) | GXY | 2024-04-15 | 14 |
| K182112 | Sense System with IBT Electrodes | GXY | 2018-10-05 | 60 |
| K173571 | Element System with IBT Electrodes | GXY | 2018-03-21 | 121 |
| K101386 | VIGILANT EEG MONITOR MODEL VIGILANT 2.0 | GWQ | 2010-07-30 | 73 |
| K091963 | VIGILANT EEG MONITOR, VIGILANT 2.0 | OLT | 2009-11-06 | 128 |
| K072382 | MODEL I-2000 MONITOR | OLT | 2008-02-15 | 175 |
Recalls
openFDA lists no recalls under a recalling firm named Infinite Biomedical Technologies, LLC.
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 Infinite Biomedical Technologies, LLC is the lead sponsor of 4 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07222085: Long-Term Stability of the Glide Control Strategy (Recruiting, started 2025-10-15)
- NCT06539936: Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses (Recruiting, started 2024-09-16)
- NCT05888428: Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss (Recruiting, started 2024-02-02)
- NCT04043234: RESCU System for Robust Upper Limb Prosthesis Control (Completed, started 2023-11-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under Infinite Biomedical Technologies, LLC?
FDA lists 6 510(k) clearances under the applicant name “Infinite Biomedical Technologies, LLC” (first 2008, latest 2024), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Infinite Biomedical Technologies, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Infinite Biomedical Technologies, LLC is 97 days. Since 2017: 60 days, versus 145 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Infinite Biomedical Technologies, LLC?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 3); OLT (Non-Normalizing Quantitative Electroencephalograph Software, 2); GWQ (Full-Montage Standard Electroencephalograph, 1).
Next steps
- See all 6 Infinite Biomedical Technologies, LLC clearances with predicates and recalls
- Run predicate analysis for product code GXY, Infinite Biomedical Technologies, LLC'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.