510(k) · Cleared
ClearedK-L-W Intraoral Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Aug 18, 1999 as substantially equivalent to K973275 (KLS-Martin L.P., 1997) after a 77-day review. Its family tree reaches back 3 generations to 1979. 3 later devices descend from it.
- Decided
- Aug 18, 1999
- Review
- 77 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K792561 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 2 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 1 generation backK973275 KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997
- This deviceK991875 K-L-W Intraoral DistractorKLS-Martin L.P. · 1999
- Descendant · cites it directly · 1 of its ownK161470 Internal Distraction - SterileKLS Martin L.P. · 2016
- Descendant · 2 generations on · 0 of its ownK220050 KLS Martin IPS DistractionKLS Martin L.P. · 2022
- Descendant · cites it directly · 0 of its ownK100833 Syle SmartipOsspray, Ltd. · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −2 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −1 | K973275 | KLS-Martin Intraoral Distractor | KLS-Martin L.P. | 1997 | — |
| 0 (this device) | K991875 | K-L-W Intraoral Distractor | KLS-Martin L.P. | 1999 | — |
| +1 | K161470 | Internal Distraction - Sterile | KLS Martin L.P. | 2016 | — |
| +2 | K220050 | KLS Martin IPS Distraction | KLS Martin L.P. | 2022 | — |
| +1 | K100833 | Syle Smartip | Osspray, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQN? 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 MQN device
- #1 K220050 KLS Martin IPS Distractionscore 5.0 · 5 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973275 | KLS-Martin Intraoral DistractorSummary page 1…6-7186 Ed Ransom or Pat Lamb June 1,1999 K-L-W Intraoral Distractor Intraoral Distractor KLS Intraoral Distractor Distractor similar to the KLS distractor approved as K973275 The intended use is for the gradual bone distraction of the facial bones that are deformed due to birth defects, disease, or tra… | 1997 |
What descends from it? (3)
2 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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K161470 (KLS Martin L.P., 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K973275.
How does its category compare?
All MQN devicesMQN External Mandibular Fixator And/Or Distractor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MQN
292in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQN
34in 2025
MAUDE reports naming product code MQN, 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 | 4 | 77 | 0 | 5 |
| 2008 | 3 | 292 | 0 | 8 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 1 | — | 0 | 107 |
| 2013 | 0 | — | 0 | 179 |
| 2014 | 1 | — | 1 | 57 |
| 2015 | 1 | — | 0 | 93 |
| 2016 | 1 | — | 0 | 87 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 1 | — | 0 | 108 |
| 2019 | 1 | — | 0 | 122 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 101 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indications for use are an uni-directional, intro-oral device for the distraction of facial bones.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991875 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991875: K-L-W Intraoral Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991875
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026