510(k) · Cleared
ClearedTeca Model-10 Electromyograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teca, Inc. · IKN Electromyograph, Diagnostic
Cleared on Nov 26, 1980 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.
- Decided
- Nov 26, 1980
- Review
- 35 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 4 citing it directly.
- This deviceK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
- Descendant · cites it directly · 21 of its ownK982359 NC-StatNeurometrix, Inc. · 1998
- Descendant · cites it directly · 20 of its ownK013459 Modification of NC-StatNeurometrix, Inc. · 2002
- Descendant · cites it directly · 19 of its ownK041320 Modification to NC-StatNeurometrix, Inc. · 2004
- Descendant · cites it directly · 18 of its ownK060584 NC-StatNeurometrix, Inc. · 2006
- Descendant · 2 generations on · 15 of its ownK070109 Neurometrix AdvanceNeurometrix, Inc. · 2008
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K982359NC-StatNeurometrix, Inc. · 1998 · cites it directly21descendants
- K013459Modification of NC-StatNeurometrix, Inc. · 2002 · cites it directly20descendants
- K041320Modification to NC-StatNeurometrix, Inc. · 2004 · cites it directly19descendants
- K060584NC-StatNeurometrix, Inc. · 2006 · cites it directly18descendants
- K070109Neurometrix AdvanceNeurometrix, Inc. · 2008 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K802637 | Teca Model-10 Electromyograph | Teca, Inc. | 1980 | — |
| +1 | K982359 | NC-Stat | Neurometrix, Inc. | 1998 | — |
| +1 | K013459 | Modification of NC-Stat | Neurometrix, Inc. | 2002 | — |
| +1 | K041320 | Modification to NC-Stat | Neurometrix, Inc. | 2004 | — |
| +1 | K060584 | NC-Stat | Neurometrix, Inc. | 2006 | — |
| +2 | K070109 | Neurometrix Advance | Neurometrix, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 IKN? 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? (22)
See all 224 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K982359 (Neurometrix, Inc., 1998) has gone furthest, with 21 descendants of its own.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IKN
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · IKN
188in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IKN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKN
3in 2025
MAUDE reports naming product code IKN, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 24 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 3 | 188 | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K802637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K802637: Teca Model-10 Electromyograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802637
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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