510(k) · Cleared
ClearedLOTUS
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 Dec 16, 2003 as substantially equivalent to K980099 (Ethicon Endo-Surgery, Inc., 1998) and 1 other predicate after a 133-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Dec 16, 2003
- Review
- 133 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925699 (1993). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK925699 Harmonic Scalpel Laparosonic Clamp Coagulator Acc.Ultracision, Inc. · 1993
- 1 generation backK980099 Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc. · 1998
- This deviceK032424 LOTUSSra Developments, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK063531 Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007
- Descendant · 2 generations on · 1 of its ownK151101 Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK221102 LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K063531Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007 · cites it directly2descendants
- K151101Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd. · 2015 · 2 generations on1descendant
- K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925699 | Harmonic Scalpel Laparosonic Clamp Coagulator Acc. | Ultracision, Inc. | 1993 | — |
| −1 | K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| 0 (this device) | K032424 | LOTUS | Sra Developments, Ltd. | 2003 | — |
| +1 | K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery System | Sra Developments, Ltd. | 2007 | — |
| +2 | K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | Sra Developments, Ltd. | 2015 | — |
| +3 | 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 |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Summary page 1…DEVICES The LOTUS Laparoscopic Ultrasound Surgery System is substantially equivalent to the UltraCision Laparoscopic Coagulating Shears cleared by FDA as K980099), and to the AutoSuture Ultrasonic Surgical Instrument (K971861). B. DEVICE DESCRIPTION The LOTUS (Lanaroscopi Oper… | 1998 |
| * | K971861 | Ultrasonic Hand InstrumentsSummary page 1…stantially equivalent to the UltraCision Laparoscopic Coagulating Shears cleared by FDA as K980099), and to the AutoSuture Ultrasonic Surgical Instrument (K971861). B. DEVICE DESCRIPTION The LOTUS (Lanaroscopi Operation by Torsional U~traSound) system consists of the power modu… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery System | 2007 | 2 |
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 10 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063531 (Sra Developments, Ltd., 2007) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K980099.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The LOTUS Laproscopic Ultrasound Surgery System is 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, gynecologic, and thoracic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032424: LOTUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032424
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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