510(k) · Cleared
ClearedSleep-in Bone Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Influence, Inc. · LRK Device, Anti-Snoring
Cleared on Aug 25, 1997 as substantially equivalent to K970292 (Influence, Inc., 1997) and 4 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1992. 23 later devices descend from it.
- Decided
- Aug 25, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K920213 (1992). 9 ancestors in all. 23 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 2 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 1 generation backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- This deviceK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- Descendant · cites it directly · 16 of its ownK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
- Descendant · cites it directly · 15 of its ownK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
- Descendant · 2 generations on · 14 of its ownK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
- Descendant · 3 generations on · 13 of its ownK110127 Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011
- Descendant · 4 generations on · 6 of its ownK111179 Encore Tongue Suspension System (Monofilament #1 Suspension Suture)…Siesta Medical, Inc. · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K981677Repose Bone Screw SystemInfluence, Inc. · 1999 · cites it directly16descendants
- K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010 · cites it directly15descendants
- K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010 · 2 generations on14descendants
- K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011 · 3 generations on13descendants
- K111179Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue…Siesta Medical, Inc. · 2011 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −2 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −1 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| 0 (this device) | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| +1 | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | 2 |
| +1 | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension System | Siesta Medical, Inc. | 2010 | — |
| +2 | K103179 | Prelude II Tounge Suspension System | Siesta Medical, Inc. | 2010 | — |
| +3 | K110127 | Prelude Iii Tongue Suspension System | Siesta Medical, Inc. | 2011 | — |
| +4 | K111179 | Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore… | Siesta Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 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), 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 LRK? 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 LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewSummary page 1…ion Name: The Sleep-In™ Bone Screw System has not yet been classified. Predicate Devices: Sleep-In™ Bone Screw and Sleep-In™ Bone Inserter: e In-Fast™ Bone Screw System (K970292) e Mitek GII Anchor (K920213) e PM Positioner™ (K953293 & K955503) e Snor-X Mouthguard (K954324) Sleep-In™ Suture Passer: e Prot… | 1997 |
| * | K920213 | Mitek Anchor, Mitek Anchor IISummary page 1…Screw System has not yet been classified. Predicate Devices: Sleep-In™ Bone Screw and Sleep-In™ Bone Inserter: e In-Fast™ Bone Screw System (K970292) e Mitek GII Anchor (K920213) e PM Positioner™ (K953293 & K955503) e Snor-X Mouthguard (K954324) Sleep-In™ Suture Passer: e Protecta-Pass™ Suture Passer (K93… | 1992 |
| * | K953293 | PM PositionerSummary page 1…en classified. Predicate Devices: Sleep-In™ Bone Screw and Sleep-In™ Bone Inserter: e In-Fast™ Bone Screw System (K970292) e Mitek GII Anchor (K920213) e PM Positioner™ (K953293 & K955503) e Snor-X Mouthguard (K954324) Sleep-In™ Suture Passer: e Protecta-Pass™ Suture Passer (K932925) \\\DC - 65853/3 - 04… | 1995 |
| * | K955503 | Adjustable PM PositionerSummary page 1…ied. Predicate Devices: Sleep-In™ Bone Screw and Sleep-In™ Bone Inserter: e In-Fast™ Bone Screw System (K970292) e Mitek GII Anchor (K920213) e PM Positioner™ (K953293 & K955503) e Snor-X Mouthguard (K954324) Sleep-In™ Suture Passer: e Protecta-Pass™ Suture Passer (K932925) \\\DC - 65853/3 - 0461870.01… | 1996 |
| * | K954324 | Snor-X Mouth GuardSummary page 1…In™ Bone Screw and Sleep-In™ Bone Inserter: e In-Fast™ Bone Screw System (K970292) e Mitek GII Anchor (K920213) e PM Positioner™ (K953293 & K955503) e Snor-X Mouthguard (K954324) Sleep-In™ Suture Passer: e Protecta-Pass™ Suture Passer (K932925) \\\DC - 65853/3 - 0461870.01 Performance Sta… | 1995 |
| Kept off the family tree | K932925 | FDA’s K932925 is Bone Anchor for Soft Tissue Attachment Our OCR of the scanned summary read K932925, FDA’s number for Bone Anchor for Soft Tissue Attachment (Vesitec Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Protecta-Pass™ Suture Passer”. Kept off the family tree. Summary page 1…ystem (K970292) e Mitek GII Anchor (K920213) e PM Positioner™ (K953293 & K955503) e Snor-X Mouthguard (K954324) Sleep-In™ Suture Passer: e Protecta-Pass™ Suture Passer (K932925) \\\DC - 65853/3 - 0461870.01 Performance Standards: No performance standards applicable to the bone screw syst… | 1994 |
What descends from it? (23)
See all 233 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 5 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K981677 (Influence, Inc., 1999) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K970292.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, 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 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
The Sleep-In™ Bone Screw System is intended for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
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/K972023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972023: Sleep-in Bone Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972023
Report an extraction error
Are you the manufacturer?
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