510(k) · Cleared
ClearedLOTUS Series 4 Enhanced Shears, LOTUS Series 5
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 15, 2022 as substantially equivalent to K151101 (Sra Developments, Ltd., 2015) after a 245-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Dec 15, 2022
- Review
- 245 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K900003 (1990). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK900003 System Ten Model 100 Surgical SystemAdvanced Osseous Technologies · 1990
- 4 generations backK961725 Oscar Orthosonics System for Cemented Arthroplasty RevisionC.L. Mcintosh & Assoc., Inc. · 1996
- 3 generations backK021502 Oscar, Model OE3000Orthosonics, Ltd. · 2002
- 2 generations backK063531 Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007
- 1 generation backK151101 Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd. · 2015
- This deviceK221102 LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900003 | System Ten Model 100 Surgical System | Advanced Osseous Technologies | 1990 | — |
| −4 | K961725 | Oscar Orthosonics System for Cemented Arthroplasty Revision | C.L. Mcintosh & Assoc., Inc. | 1996 | — |
| −3 | K021502 | Oscar, Model OE3000 | Orthosonics, Ltd. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K151101 | Lotus Series 4 Ultrasonic Surgical System & AccessoriesSummary page 4…nhanced Shears and LOTUS Series 5 device are substantially equivalent to those registered as part of Lotus Series 4 Ultrasonic Surgical System and Accessories (K151101). Page 1 of 13… | 2015 |
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 32 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 14 ancestors has a recall.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
LOTUS Series 4 Enhanced Shears LOTUS Enhanced Shears are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. They 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). LOTUS Series 5 The Lotus Series 5 is indicated for soft tissue surgical…
Read the full statement (109 words)
LOTUS Series 4 Enhanced Shears
LOTUS Enhanced Shears are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. They 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).
LOTUS Series 5
The Lotus Series 5 is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It 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/K221102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221102: LOTUS Series 4 Enhanced Shears, LOTUS Series 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221102
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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