510(k) · Cleared
ClearedNuVasive NuvaLine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · LLZ System, Image Processing, Radiological
Cleared on Sep 26, 2019 as substantially equivalent to K162647 (Nu Vasive, Incorporated, 2017) after a 21-day review. Its family tree reaches back 13 generations to 1984.
- Decided
- Sep 26, 2019
- Review
- 21 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K842956 (1984). 87 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 9 generations between
- 3 generations backK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- 2 generations backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- 1 generation backK162647 NuVasive NuvaLine Mobile AppNu Vasive, Incorporated · 2017
- This deviceK192435 NuVasive NuvaLineNu Vasive, Incorporated · 2019
Show all 13 generations
- Root · 13 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 12 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 11 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 10 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 9 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 8 generations backK061113 OrthomonAxon Systems, Inc. · 2006
- 7 generations backK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- 6 generations backK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- 5 generations backK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- 4 generations backK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- 3 generations backK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- 2 generations backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- 1 generation backK162647 NuVasive NuvaLine Mobile AppNu Vasive, Incorporated · 2017
- This deviceK192435 NuVasive NuvaLineNu Vasive, Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −12 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −11 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −10 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −9 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −8 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| −7 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| −6 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| −5 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| −4 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| −3 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
| −2 | K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016 | — |
| −1 | K162647 | NuVasive NuvaLine Mobile App | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K192435 | NuVasive NuvaLine | Nu Vasive, Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162647 | NuVasive NuvaLine Mobile AppSummary page 4…de: LLZ C. Predicate Devices The subject NuVasive NuvaLine is substantially equivalent to the primary predicate NuVasive NuvaLine Mobile App (K162647) and additional reference devices NuVasive NVM5 System (K152942), Nemaris Surgimap 2.0 (K141669), and NucleusHealth Nucleus… | 2017 |
| † | K152942 | NuVasiveNVM5 System | 2016 |
| † | K141669 | Surgimap | 2014 |
| † | K171130 | Nucleus Image Management System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 87 ancestors have a recall of any class.
- 1 other device also cites its predicate K162647.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
NuVasive NuvaLine is a medical device software application intended to assist healthcare professionals in capturing, viewing, measuring, and storage and distribution of spinal alignment assessment images at various time points in patient care. Online synchronization of the database allows healthcare professionals and service providers to conveniently perform and review spinal alignment assessments of images by featuring measurement tools on various platforms. Clinical judgment and experience are required to properly use the software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192435: NuVasive NuvaLine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192435
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026