Bioness, Inc.: FDA clearances and approvals
Bioness, Inc. has 13 FDA 510(k) clearances (first 2011, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time: 107 days. Since 2017 its median was 94 days, against 218 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 6 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 68 |
| 2013 | 1 | 159 |
| 2014 | 0 | — |
| 2015 | 1 | 175 |
| 2016 | 0 | — |
| 2017 | 1 | 151 |
| 2018 | 1 | 98 |
| 2019 | 3 | 90 |
| 2020 | 2 | 30 |
| 2021 | 0 | — |
| 2022 | 1 | 244 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bioness, Inc.'s cleared 510(k)s took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 218 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | 9 | 9 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | 4 | 4 |
Review panels
- Neurology (13)
Most recent Bioness, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211965 | StimRouter Neuromodulation System | GZF | 2022-02-23 | 244 |
| K200482 | StimRouter Neuromodulation System | GZF | 2020-03-27 | 29 |
| K200262 | L100 Go System | GZI | 2020-03-04 | 30 |
| K190047 | StimRouter Neuromodulation System | GZF | 2019-10-31 | 295 |
| K191587 | L360 Thigh System | GZI | 2019-09-12 | 90 |
| K190285 | L300 Go System | GZI | 2019-03-14 | 31 |
| K173682 | L300 Go System | GZI | 2018-03-09 | 98 |
| K162407 | L300 Go System | GZI | 2017-01-27 | 151 |
| K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit | GZF | 2015-02-20 | 175 |
| K123636 | H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE | GZI | 2013-05-01 | 159 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bioness, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Bioness, Inc. is the industry lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03913689: StimRouter Registry Clinical Protocol (Completed, started 2019-06-26)
- NCT01592344: Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy (Completed, started 2012-04)
- NCT01237860: Evaluation of the Safety and Performance of the NESS L300 Plus System (Completed, started 2010-09)
- NCT01138995: Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop (Completed, started 2010-05)
- NCT00665132: Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves (Completed, started 2008-04)
Frequently asked questions
How many FDA 510(k) clearances does Bioness, Inc. have?
Bioness, Inc. has 13 FDA 510(k) clearances (first 2011, latest 2022), across 2 product codes in 1 review panel.
How long does FDA take to clear Bioness, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bioness, Inc.'s cleared 510(k)s is 107 days. Since 2017: 94 days, versus 218 days for all cleared 510(k)s in the same product codes.
What devices does Bioness, Inc. make?
Its most frequent FDA product codes are GZI (Stimulator, Neuromuscular, External Functional, 9); GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief), 4).
Has Bioness, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bioness, Inc. Related entities may recall under other names.
Next steps
- See all 13 Bioness, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZI, Bioness, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.