510(k) · Cleared
ClearedOsstell Resonance Frequency Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integration Diagnostics, Ltd. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Aug 9, 2001 after a 251-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
- Aug 9, 2001
- Review
- 251 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK003714 Osstell Resonance Frequency AnalyzerIntegration Diagnostics, Ltd. · 2001
- Descendant · cites it directly · 10 of its ownK033689 Osstell Mentor RfaIntegration Diagnostics, Ltd. · 2004
- Descendant · 2 generations on · 9 of its ownK082523 Osstell Isq Implant Stability MeterOsstell AB · 2008
- Descendant · 3 generations on · 3 of its ownK143445 Tellos ISQ BuddyTellos Medical AB · 2016
- Descendant · 3 generations on · 2 of its ownK181888 Osstell BeaconOsstell AB · 2019
- Descendant · 4 generations on · 1 of its ownK241065 ChecQ (AC100)Dentis Co., Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K033689Osstell Mentor RfaIntegration Diagnostics, Ltd. · 2004 · cites it directly10descendants
- K082523Osstell Isq Implant Stability MeterOsstell AB · 2008 · 2 generations on9descendants
- K143445Tellos ISQ BuddyTellos Medical AB · 2016 · 3 generations on3descendants
- K181888Osstell BeaconOsstell AB · 2019 · 3 generations on2descendants
- K241065ChecQ (AC100)Dentis Co., Ltd. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003714 | Osstell Resonance Frequency Analyzer | Integration Diagnostics, Ltd. | 2001 | — |
| +1 | K033689 | Osstell Mentor Rfa | Integration Diagnostics, Ltd. | 2004 | — |
| +2 | K082523 | Osstell Isq Implant Stability Meter | Osstell AB | 2008 | — |
| +3 | K143445 | Tellos ISQ Buddy | Tellos Medical AB | 2016 | — |
| +3 | K181888 | Osstell Beacon | Osstell AB | 2019 | — |
| +4 | K241065 | ChecQ (AC100) | Dentis Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 EKX? 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 EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 5 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 |
|---|---|---|---|
| K033689 | Osstell Mentor Rfa | 2004 | 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, K033689 (Integration Diagnostics, Ltd., 2004) has gone furthest, with 10 descendants of its own.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, 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 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K003714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003714: Osstell Resonance Frequency Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003714
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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