510(k) · Cleared
ClearedNess L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness L300 System Kit, Right, Small Ness L300 System Kit,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioness, Inc. · GZI Stimulator, Neuromuscular, External Functional
Cleared on Apr 20, 2012 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Apr 20, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK120853 Ness L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness…Bioness, Inc. · 2012
- Descendant · cites it directly · 10 of its ownK122784 Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit…Bioness, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK162407 L300 Go SystemBioness, Inc. · 2017
- Descendant · 3 generations on · 7 of its ownK173682 L300 Go SystemBioness, Inc. · 2018
- Descendant · 4 generations on · 5 of its ownK190285 L300 Go SystemBioness, Inc. · 2019
- Descendant · 5 generations on · 2 of its ownK213622 Cionic Neural Sleeve NS-100Cionic · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K122784Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model LG3-5000…Bioness, Inc. · 2012 · cites it directly10descendants
- K162407L300 Go SystemBioness, Inc. · 2017 · 2 generations on9descendants
- K173682L300 Go SystemBioness, Inc. · 2018 · 3 generations on7descendants
- K190285L300 Go SystemBioness, Inc. · 2019 · 4 generations on5descendants
- K213622Cionic Neural Sleeve NS-100Cionic · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120853 | Ness L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness L300… | Bioness, Inc. | 2012 | — |
| +1 | K122784 | Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model… | Bioness, Inc. | 2012 | — |
| +2 | K162407 | L300 Go System | Bioness, Inc. | 2017 | — |
| +3 | K173682 | L300 Go System | Bioness, Inc. | 2018 | — |
| +4 | K190285 | L300 Go System | Bioness, Inc. | 2019 | — |
| +5 | K213622 | Cionic Neural Sleeve NS-100 | Cionic | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZI device
- #1 K243828 Cionic Neural Sleeve (NS-200)score 12.9 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122784 | Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model LG3-5000… | 2012 | 10 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122784 (Bioness, Inc., 2012) has gone furthest, with 10 descendants of its own.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZI
110in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZI
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZI
3in 2025
MAUDE reports naming product code GZI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 81 | 0 | 1 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 6 | 139 | 0 | 3 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 299 | 0 | 2 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 6 | 168 | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 4 | 110 | 0 | 3 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K120853 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120853: Ness L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness L300 System Kit, Right, Small Ness L300 System Kit,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120853
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026