510(k) · Cleared
ClearedXPS Straightshot or Model 2000 Microdebrider System or XPS Powersculpt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · QPB System, Suction, Lipoplasty For Removal
Cleared on Jan 21, 2000 as substantially equivalent to K981922 (Microaire Surgical Instruments, Inc., 1998) and 1 other predicate after a 150-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.
- Decided
- Jan 21, 2000
- Review
- 150 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832520 (1983). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK832520 Suction TipsWells Johnson Co. · 1983
- This deviceK992855 XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptXomed, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK021813 Hydrocision General Surgery Fluidjet SystemHydrocision, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK010666 XPS 3000 System with Reciprocating Adapter and Suction CannulaeMedtronic Xomed, Inc. · 2001
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832520 | Suction Tips | Wells Johnson Co. | 1983 | — |
| 0 (this device) | K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS Powersculpt | Xomed, Inc. | 2000 | — |
| +1 | K021813 | Hydrocision General Surgery Fluidjet System | Hydrocision, Inc. | 2003 | — |
| +1 | K010666 | XPS 3000 System with Reciprocating Adapter and Suction Cannulae | Medtronic Xomed, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K981922 | Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument…Summary page 6…ivalent to the following predicate devices that are currently marketed to dissect and remove adipose tissue: Powered Systems MicroAire PAD-100 “Power Aspiration Device” K981922 (MicroAire Surgical Instruments) NuMED Power Cannula 510k unknown (NuMED or United American Medical) Aspiration Cannulae Variou… | 1998 |
| * | K832520 | Suction TipsSummary page 6…ice” K981922 (MicroAire Surgical Instruments) NuMED Power Cannula 510k unknown (NuMED or United American Medical) Aspiration Cannulae Various cannulae (and aspirators) K832520 (Wells Johnson Company Like the predicate powered systems, the XPS/PowerSculpt System consists mainly of a console, a handpiece… | 1983 |
| * | — | NuMED Power Cannula Named without a submission number | |
| † | K984363 | XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider System | 1999 |
| † | K983025 | Xomed Feathertouch XPS Power Rasp Attachment | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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 XPS/PowerSculpt System with reciprocating adapter and suction cannula is indicated for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.
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/K992855 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992855: XPS Straightshot or Model 2000 Microdebrider System or XPS Powersculpt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992855
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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