510(k) · Cleared
ClearedNti Tension Suppression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nti-Tss, Inc. · OCO Mouthguard, Migraine/Tension Headache
Cleared on Jun 20, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 63 later devices descend from it.
- Decided
- Jun 20, 2001
- Review
- 89 days
- Class
- Class U
- Product code
- OCO
- Recalls
- None
- Predicates
- 0
63 later devices descend from it, 6 citing it directly.
- This deviceK010876 Nti Tension Suppression SystemNti-Tss, Inc. · 2001
- Descendant · cites it directly · 46 of its ownK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- Descendant · 2 generations on · 19 of its ownK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK082723 GrindguardGrind Guard Technologies, LLC · 2009
- Descendant · 2 generations on · 9 of its ownK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- Descendant · cites it directly · 9 of its ownK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K022809EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003 · cites it directly46descendants
- K072147Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007 · 2 generations on19descendants
- K082723GrindguardGrind Guard Technologies, LLC · 2009 · cites it directly10descendants
- K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc. · 2013 · 2 generations on9descendants
- K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010876 | Nti Tension Suppression System | Nti-Tss, Inc. | 2001 | — |
| +1 | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| +2 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| +1 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| +2 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| +1 | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite) | Bryan Keropian Dds | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 OCO? 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 OCO device
- #1 K202523 TMJ Relaxscore 1.6 · 1 generation · no Class I recall
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? (63)
See all 636 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, K022809 (Power Products, Inc.-Splintek, 2003) has gone furthest, with 46 descendants of its own.
How does its category compare?
All OCO devicesOCO Mouthguard, Migraine/Tension Headache: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCO
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OCO
Too few OCO 510(k)s in any year since 2007 to give a median.
Recalls per year · OCO
No recall names OCO since 2007.
Adverse event reports per year · OCO
5in 2023
MAUDE reports naming product code OCO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K010876 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010876: Nti Tension Suppression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010876
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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