510(k) · Cleared
Recalled · Class I · 2019Mcghan Magna-Site (TM) Tissue Expander
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mcghan Medical Corp. · LCJ Tissue Expander And Accessories
Cleared on Jul 23, 1986 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 5 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 4 times, including 3 Class I recalls.
- Decided
- Jul 23, 1986
- Review
- 43 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- 4 (3 Class I)
- Predicates
- 0
4 later devices descend from it, 2 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- This deviceK862203 Mcghan Magna-Site (TM) Tissue ExpanderMcghan Medical Corp. · 1986
- Descendant · cites it directly · 1 of its ownK102806 Natrelle 133 Tissue Expander with Suture TabsAllergan Medical · 2011 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK972109 Spacemaker Surgicalballoon Dissector/ExpanderGeneral Surgical Innovations · 1997
- Descendant · 2 generations on · 0 of its ownK112534 Lifecell Tissue ExpanderLifecell Corp. · 2012
- Descendant · 2 generations on · 0 of its ownK080158 LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC · 2008
Class I recalls in this family
- K102806 Natrelle 133 Tissue Expander with Suture Tabscites it directly · 2011
Most influential descendants
Showing 4 of 4 · See all- K102806Natrelle 133 Tissue Expander with Suture TabsAllergan Medical · 2011 · cites it directly1descendant
- K972109Spacemaker Surgicalballoon Dissector/ExpanderGeneral Surgical Innovations · 1997 · cites it directly1descendant
- K112534Lifecell Tissue ExpanderLifecell Corp. · 2012 · 2 generations on0descendants
- K080158LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862203 | Mcghan Magna-Site (TM) Tissue Expander | Mcghan Medical Corp. | 1986 | — |
| +1 | K102806 | Natrelle 133 Tissue Expander with Suture Tabs | Allergan Medical | 2011 | Class I |
| +1 | K972109 | Spacemaker Surgicalballoon Dissector/Expander | General Surgical Innovations | 1997 | — |
| +2 | K112534 | Lifecell Tissue Expander | Lifecell Corp. | 2012 | — |
| +2 | K080158 | LB Medical Inflatable Tissue Elevator/Expander System | Lb Medical LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 1 | 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.
2 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 LCJ device
- #1 K254126 Natrelle 133S Tissue Expandersscore 11.6 · 4 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2019 | Class I | Z-2455-2019 | Unknown/Undetermined by firm | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. |
| Jul 24, 2019 | Class I | Z-2457-2019 | Unknown/Undetermined by firm | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. |
| Jul 24, 2019 | Class I | Z-2458-2019 | Unknown/Undetermined by firm | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. |
| Jun 18, 2015 | Class II | Z-2103-2015 | Incorrect or no expiration date | Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life. |
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.
- K102806Natrelle 133 Tissue Expander with Suture TabsAllergan Medical · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K102806 (Allergan Medical, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCJ
525in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCJ
496in 2025
MAUDE reports naming product code LCJ, 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 | 10 |
| 2008 | 0 | — | 0 | 24 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 58 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 31 |
| 2013 | 1 | — | 0 | 47 |
| 2014 | 3 | 256 | 0 | 20 |
| 2015 | 2 | — | 0 | 13 |
| 2016 | 3 | 153 | 0 | 38 |
| 2017 | 0 | — | 0 | 111 |
| 2018 | 3 | 29 | 0 | 518 |
| 2019 | 0 | — | 0 | 554 |
| 2020 | 0 | — | 0 | 639 |
| 2021 | 0 | — | 0 | 440 |
| 2022 | 0 | — | 0 | 499 |
| 2023 | 3 | 525 | 1 | 473 |
| 2024 | 1 | — | 0 | 488 |
| 2025 | 2 | — | 0 | 496 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K862203 · printed Nov 4, 2026
Cite this page
510(k) Report. “K862203: Mcghan Magna-Site (TM) Tissue Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862203
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