510(k) · Cleared
Recalled · Class II · 2015Microaire Surgical Instruments LLC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microaire Surgical Instruments, LLC · QPB System, Suction, Lipoplasty For Removal
Cleared on Aug 17, 2012 as substantially equivalent to K022051 (Sound Surgical Technologies, LLC, 2002) after a 298-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 17, 2012
- Review
- 298 days
- Class
- Class II
- Product code
- QPB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910696 (1991). 19 ancestors in all, the oldest K884413 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 3 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 2 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 1 generation backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- This deviceK113128 Microaire Surgical Instruments LLCMicroaire Surgical Instruments, LLC · 2012
- Descendant · cites it directly · 0 of its ownK171242 Alma LipoFlow SystemAlma Lasers, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K171242Alma LipoFlow SystemAlma Lasers, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −3 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −2 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −1 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| 0 (this device) | K113128 | Microaire Surgical Instruments LLC | Microaire Surgical Instruments, LLC | 2012 | — |
| +1 | K171242 | Alma LipoFlow System | Alma Lasers, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 QPB? 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 QPB device
- #1 K212024 PAL Systemscore 13.7 · 5 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 |
|---|---|---|---|
| * | K022051 | Soundvaser SystemSummary page 5…System Classification: Lipoplasty Suction System (21 CFR 878.5040, Product Code MUU) 4) Predicate Device: Sound Surgical Technologies LLC - SoundVaser System (K022051) 5) Device Description: The MicroAire LipoTower System isa modular wheeled cart that contains an adjustable vacuum source… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171242 | Alma LipoFlow System | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2015 | Class II | Z-2821-2015 | Device Design | There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails. |
| Jun 12, 2015 | Class II | Z-2822-2015 | Device Design | There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K171242 (Alma Lasers, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K022051.
How does its category compare?
All QPB devicesQPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · QPB
5so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QPB
194in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QPB
No recall names QPB since 2007.
Adverse event reports per year · QPB
16in 2025
MAUDE reports naming product code QPB, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 69 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 234 | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 4 | 194 | 0 | 16 |
| 2025 | 2 | — | 0 | 16 |
| 2026 | 5 | 238 | 0 | — |
What is it indicated for?
The MicroAire LipoTower System is indicated for use in the following surgical specialties when
the fragmentation, emulsification, and aspiration of soft tissue is desired:
- Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery
- Urological Surgery
- Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery
- Gynecological Surgery
- Thoracic Surgery
- Laparoscopic Surgery
The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification,
and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113128: Microaire Surgical Instruments LLC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113128
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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