510(k) · Cleared
ClearedAdjustable PM Positioner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jonathan A. Parker, D.D.S. · LQZ Device, Jaw Repositioning
Cleared on Feb 8, 1996 after a 69-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 30 later devices descend from it.
- Decided
- Feb 8, 1996
- Review
- 69 days
- Class
- Class II
- Product code
- LQZ
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 4 citing it directly.
- This deviceK955503 Adjustable PM PositionerJonathan A. Parker, D.D.S. · 1996
- Descendant · cites it directly · 23 of its ownK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- Descendant · 2 generations on · 16 of its ownK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 15 of its ownK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
- Descendant · 3 generations on · 14 of its ownK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
- Descendant · 4 generations on · 13 of its ownK110127 Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K972023Sleep-in Bone Screw SystemInfluence, Inc. · 1997 · cites it directly23descendants
- K981677Repose Bone Screw SystemInfluence, Inc. · 1999 · 2 generations on16descendants
- K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010 · 2 generations on15descendants
- K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010 · 3 generations on14descendants
- K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955503 | Adjustable PM Positioner | Jonathan A. Parker, D.D.S. | 1996 | — |
| +1 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| +2 | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | 2 |
| +2 | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension System | Siesta Medical, Inc. | 2010 | — |
| +3 | K103179 | Prelude II Tounge Suspension System | Siesta Medical, Inc. | 2010 | — |
| +4 | K110127 | Prelude Iii Tongue Suspension System | Siesta Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 LQZ? 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 LQZ device
- #1 K233754 AIO Breathescore 12.9 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (30)
See all 304 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, K972023 (Influence, Inc., 1997) has gone furthest, with 23 descendants of its own.
How does its category compare?
All LQZ devicesLQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LQZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LQZ
Too few LQZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LQZ
No recall names LQZ since 2007.
Adverse event reports per year · LQZ
2in 2021
MAUDE reports naming product code LQZ, 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 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K955503 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955503: Adjustable PM Positioner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955503
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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