510(k) · Cleared
ClearedSeries 3 Lotus Laparoscopic Ultrasound Surgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sra Developments, Ltd. · LFL Instrument, Ultrasonic Surgical
Cleared on Feb 22, 2007 as substantially equivalent to K032424 (Sra Developments, Ltd., 2003) and 3 other predicates after a 92-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it.
- Decided
- Feb 22, 2007
- Review
- 92 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K900003 (1990). 12 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK900003 System Ten Model 100 Surgical SystemAdvanced Osseous Technologies · 1990
- 2 generations backK961725 Oscar Orthosonics System for Cemented Arthroplasty RevisionC.L. Mcintosh & Assoc., Inc. · 1996
- 1 generation backK021502 Oscar, Model OE3000Orthosonics, Ltd. · 2002
- This deviceK063531 Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007
- Descendant · cites it directly · 1 of its ownK151101 Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK221102 LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900003 | System Ten Model 100 Surgical System | Advanced Osseous Technologies | 1990 | — |
| −2 | K961725 | Oscar Orthosonics System for Cemented Arthroplasty Revision | C.L. Mcintosh & Assoc., Inc. | 1996 | — |
| −1 | K021502 | Oscar, Model OE3000 | Orthosonics, Ltd. | 2002 | — |
| 0 (this device) | K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery System | Sra Developments, Ltd. | 2007 | — |
| +1 | K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | Sra Developments, Ltd. | 2015 | — |
| +2 | K221102 | LOTUS Series 4 Enhanced Shears, LOTUS Series 5 | Sra Developments, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 LFL? 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 LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K032424 | LOTUSSummary page 1…Michael J. R. Young A. REASON FOR SUBMISSION This 510(k) is being filed for three main reasons. Firstly, it is to cover improvements in the existing LOTUS (K032424) which includes a new generator and ergonomically improved handsets. Secondly there are new hook handsets available tha… | 2003 |
| * | K060245 | Harmonic Scalpel Blades and ShearsSummary page 1…Laparoscopic Coagulation and Cutting System cleared for marketing under K032424, the Ultracision Harmonic Scalpel Blades and Shears cleared for marketing under K060245, the Ultracision 5mm Hard Sheath Laparoscopic Blade and Ultracision HS2 Blade (K971302) and Orthosonics OSCAR System fo… | 2006 |
| * | K971302 | Ultracision 5MM Laparosonic Hook Blades, Ultracision HS2 BladeSummary page 1…sion Harmonic Scalpel Blades and Shears cleared for marketing under K060245, the Ultracision 5mm Hard Sheath Laparoscopic Blade and Ultracision HS2 Blade (K971302) and Orthosonics OSCAR System for Cemented Arthroplasty Revision (K021502). C. DEVICE DESCRIPTION The SRA Developmen… | 1997 |
| * | K021502 | Oscar, Model OE3000Summary page 1…5, the Ultracision 5mm Hard Sheath Laparoscopic Blade and Ultracision HS2 Blade (K971302) and Orthosonics OSCAR System for Cemented Arthroplasty Revision (K021502). C. DEVICE DESCRIPTION The SRA Developments Series 3 LOTUS Laparoscopic Ultrasound Surgery System consists of the p… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | 2015 | 1 |
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 17 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K151101 (Sra Developments, Ltd., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, 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 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
Series 3 LOTUS shear & hook are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. LOTUS may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063531: Series 3 Lotus Laparoscopic Ultrasound Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063531
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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