510(k) · Cleared
ClearedMonopolar Needle Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculinum, Inc. · HLW Preamplifier, Battery-Powered, Ophthalmic
Cleared on Feb 9, 1990 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it.
- Decided
- Feb 9, 1990
- Review
- 32 days
- Class
- Class II
- Product code
- HLW
- Recalls
- None
- Predicates
- 0
56 later devices descend from it, 1 citing it directly.
- This deviceK900098 Monopolar Needle ElectrodeOculinum, Inc. · 1990
- Descendant · cites it directly · 55 of its ownK990015 Electrode NeedlesTechnomed Europe · 1999
- Descendant · 2 generations on · 50 of its ownK022914 Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002
- Descendant · 3 generations on · 35 of its ownK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- Descendant · 4 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- Descendant · 5 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K990015Electrode NeedlesTechnomed Europe · 1999 · cites it directly55descendants
- K022914Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002 · 2 generations on50descendants
- K112718Nuvasive NVM5 SystemNuvasive, Inc. · 2012 · 3 generations on35descendants
- K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 4 generations on33descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900098 | Monopolar Needle Electrode | Oculinum, Inc. | 1990 | — |
| +1 | K990015 | Electrode Needles | Technomed Europe | 1999 | — |
| +2 | K022914 | Rhythmlink International Subdermal Needle Electrodes | Rhythmlink International, LLC | 2002 | — |
| +3 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| +4 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| +5 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 HLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (56)
See all 561 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990015 | Electrode Needles | 1999 | 55 |
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, K990015 (Technomed Europe, 1999) has gone furthest, with 55 descendants of its own.
How does its category compare?
All HLW devicesHLW Preamplifier, Battery-Powered, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLW
FDA has decided no HLW device since 2007.
Median 510(k) review, days · HLW
Too few HLW 510(k)s in any year since 2007 to give a median.
Recalls per year · HLW
No recall names HLW since 2007.
Adverse event reports per year · HLW
No MAUDE report names HLW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K900098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900098: Monopolar Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900098
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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