510(k) · Cleared
ClearedLB Medical Inflatable Tissue Elevator/Expander System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lb Medical LLC · FZW Expander, Surgical, Skin Graft
Cleared on May 2, 2008 as substantially equivalent to K041454 (Kyphon, Inc., 2004) and 3 other predicates after a 100-day review. Its family tree reaches back 3 generations to 1998. 1 of the 15 devices in its family, counting itself, has a Class I recall.
- Decided
- May 2, 2008
- Review
- 100 days
- Class
- Class I
- Product code
- FZW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K981251 (1998). 14 ancestors in all, the oldest K843704 (1984). No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 2 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 1 generation backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- This deviceK080158 LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC · 2008
Class I recalls in this family
- K862203 Mcghan Magna-Site (TM) Tissue Expander2 generations back · 1986
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −2 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −1 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| 0 (this device) | K080158 | LB Medical Inflatable Tissue Elevator/Expander System | Lb Medical LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 1 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 5…and HTE - Elevator Product Code: Predicate Devices: * Preamendment: Elevator/Probe/Groove Director/Freer * K041454: KyphX Inflatable Bone Tamp * K061903: Acclarent Sinus Balloon Catheter… | 2004 |
| * | K061903 | Relieva Sinus Balloon CatheterSummary page 5…* Preamendment: Elevator/Probe/Groove Director/Freer * K041454: KyphX Inflatable Bone Tamp * K061903: Acclarent Sinus Balloon Catheter * K972109: Spacemaker Surgical Balloon… | 2006 |
| * | K972109 | Spacemaker Surgicalballoon Dissector/ExpanderSummary page 5…* K041454: KyphX Inflatable Bone Tamp * K061903: Acclarent Sinus Balloon Catheter * K972109: Spacemaker Surgical Balloon Disssector/Expander · K061937… | 1997 |
| * | K061937 | Cook Endoscopy Esophageal Dilation BalloonSummary page 5…eter * K972109: Spacemaker Surgical Balloon Disssector/Expander · K061937: Cook Esophageal Dilation Balloon Device Description: The subject device is similar to a traditional elevator, but… | 2006 |
| * | — | Preamendment: Elevator/Probe/Groove Director/Freer Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K862203Mcghan Magna-Site (TM) Tissue ExpanderMcghan Medical Corp. · 1986 · 2 generations back · ◆ in the 1986 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 5 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- 22 other devices also cite its predicate K041454.
How does its category compare?
All FZW devicesFZW Expander, Surgical, Skin Graft: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FZW
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · FZW
Too few FZW 510(k)s in any year since 2007 to give a median.
Recalls per year · FZW
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZW
433in 2025
MAUDE reports naming product code FZW, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 6 | 3 |
| 2009 | 0 | — | 0 | 72 |
| 2010 | 0 | — | 1 | 51 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 0 | — | 0 | 176 |
| 2014 | 0 | — | 0 | 76 |
| 2015 | 0 | — | 0 | 54 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 0 | — | 0 | 446 |
| 2018 | 0 | — | 0 | 480 |
| 2019 | 0 | — | 0 | 469 |
| 2020 | 0 | — | 0 | 486 |
| 2021 | 0 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 510 |
| 2023 | 0 | — | 0 | 605 |
| 2024 | 0 | — | 0 | 443 |
| 2025 | 0 | — | 0 | 433 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LB Medical Inflatable Tissue Elevator/Expander System is a surgical tool intended for use as a conventional manual elevator for orthopaedic or general surgery, including use to access the carpal tunnel region during carpal tunnel release procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080158 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080158: LB Medical Inflatable Tissue Elevator/Expander System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080158
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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