Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioness, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
244 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211965 | StimRouter Neuromodulation System | Bioness, Inc. | 2022-02-23 | 244 | 0 |
| K200482 | StimRouter Neuromodulation System | Bioness, Inc. | 2020-03-27 | 29 | 0 |
| K200262 | L100 Go System | Bioness, Inc. | 2020-03-04 | 30 | 0 |
| K190047 | StimRouter Neuromodulation System | Bioness, Inc. | 2019-10-31 | 295 | 0 |
| K191587 | L360 Thigh System | Bioness, Inc. | 2019-09-12 | 90 | 0 |
| K190285 | L300 Go System | Bioness, Inc. | 2019-03-14 | 31 | 0 |
| K173682 | L300 Go System | Bioness, Inc. | 2018-03-09 | 98 | 0 |
| K162407 | L300 Go System | Bioness, Inc. | 2017-01-27 | 151 | 0 |
| K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter | Bioness, Inc. | 2015-02-20 | 175 | 0 |
| K123636 | H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTEL | Bioness, Inc. | 2013-05-01 | 159 | 0 |
| K122784 | NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM K | Bioness, Inc. | 2012-12-27 | 107 | 0 |
| K120853 | NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMA | Bioness, Inc. | 2012-04-20 | 30 | 0 |
| K103343 | L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT | Bioness, Inc. | 2011-04-29 | 165 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda