510(k) · Cleared
ClearedSharplan 4300 & 4310 Ultrasonic Surgical Apirators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharplan Lasers, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Oct 14, 1988 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 218 devices in its family, counting itself, have a Class I recall. 217 later devices descend from it.
- Decided
- Oct 14, 1988
- Review
- 84 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 0
217 later devices descend from it, 3 citing it directly. 4 of the 218 devices in this family, counting this one, have a Class I recall.
- This deviceK883091 Sharplan 4300 & 4310 Ultrasonic Surgical ApiratorsSharplan Lasers, Inc. · 1988
- Descendant · cites it directly · 214 of its ownK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- Descendant · 2 generations on · 213 of its ownK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- Descendant · 3 generations on · 175 of its ownK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- Descendant · 4 generations on · 157 of its ownK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- Descendant · 5 generations on · 154 of its ownK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
Showing 5 of 217 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 217 · See all- K962952Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996 · cites it directly214descendants
- K972114Olympus Sonosurg SystemThe Olympus Optical Co. · 1998 · 2 generations on213descendants
- K981993Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998 · 3 generations on175descendants
- K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000 · 4 generations on157descendants
- K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · 5 generations on154descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883091 | Sharplan 4300 & 4310 Ultrasonic Surgical Apirators | Sharplan Lasers, Inc. | 1988 | — |
| +1 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| +2 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| +3 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| +4 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| +5 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 12 | 0 |
| 2014 | 14 | 0 |
| 2015 | 9 | 0 |
| 2016 | 17 | 1 |
| 2017 | 9 | 2 |
| 2018 | 15 | 0 |
| 2019 | 8 | 0 |
| 2020 | 15 | 1 |
| 2021 | 11 | 0 |
| 2022 | 10 | 0 |
| 2023 | 8 | 0 |
| 2024 | 7 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (217)
See all 2173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 11 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 11 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 12 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 13 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- Of its descendants, K962952 (Olympus Optical, Co., 1996) has gone furthest, with 214 descendants 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.
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 | — |
https://510kreport.com/device/K883091 · printed Nov 5, 2026
Cite this page
510(k) Report. “K883091: Sharplan 4300 & 4310 Ultrasonic Surgical Apirators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K883091
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026