510(k) · Cleared
ClearedOtelo LL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Jan 6, 2016 as substantially equivalent to K043602 (Medtronic Sofamor Danek, 2005) after a 257-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jan 6, 2016
- Review
- 257 days
- Class
- Class I
- Product code
- GAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002931 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002931 | Metrx System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| −1 | K043602 | Quadrant Retractor System | Medtronic Sofamor Danek | 2005 | — |
| 0 (this device) | K151104 | Otelo LL | Spineart | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 GAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K043602 | Quadrant Retractor SystemSummary page 4…GAD CFR section 878.4800 Device panel General & Plastic Surgery Legally marketed Primary predicate: Quadrant Retractor System (K043602) manufactured by predicate devices Medtronic Sofamor Danek… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K043602.
How does its category compare?
All GAD devicesGAD Retractor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GAD
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GAD
Too few GAD 510(k)s in any year since 2007 to give a median.
Recalls per year · GAD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAD
107in 2025
MAUDE reports naming product code GAD, 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 | 38 |
| 2008 | 0 | — | 1 | 45 |
| 2009 | 0 | — | 1 | 64 |
| 2010 | 0 | — | 0 | 52 |
| 2011 | 0 | — | 0 | 50 |
| 2012 | 0 | — | 0 | 80 |
| 2013 | 1 | — | 3 | 88 |
| 2014 | 0 | — | 2 | 80 |
| 2015 | 0 | — | 1 | 67 |
| 2016 | 2 | — | 0 | 78 |
| 2017 | 0 | — | 0 | 90 |
| 2018 | 0 | — | 0 | 77 |
| 2019 | 0 | — | 0 | 62 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 81 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 80 |
| 2024 | 0 | — | 1 | 111 |
| 2025 | 0 | — | 0 | 107 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The OTELO LL Retractor is intended to provide the surgeon access to the spine by dissection and traction of soft and bony tissue
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151104 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151104: Otelo LL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151104
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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