510(k) · Cleared
ClearedXPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Feb 26, 1999 as substantially equivalent to K973268 (Microaire Surgical Instruments, Inc., 1997) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1983. 3 later devices descend from it.
- Decided
- Feb 26, 1999
- Review
- 81 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K832520 (1983). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK832520 Suction TipsWells Johnson Co. · 1983
- 1 generation backK973268 Microaire Power Aspiration Device Pad SystemMicroaire Surgical Instruments, Inc. · 1997 · Recalled
- This deviceK984363 XPS Tissue Aspiration System, XPS Straightshot or Model 2000…Xomed, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK040239 Supraflow ConsoleNeomedix Corp. · 2004 · Recalled
- Descendant · 2 generations on · 1 of its ownK080845 Orwell Fluid Collection and Disposal SystemCardinalhealth · 2008
- Descendant · 3 generations on · 0 of its ownK090759 Biodrain Streamway Fluid Management SystemBiodrain Medical, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K832520 | Suction Tips | Wells Johnson Co. | 1983 | — |
| −1 | K973268 | Microaire Power Aspiration Device Pad System | Microaire Surgical Instruments, Inc. | 1997 | 1 |
| 0 (this device) | K984363 | XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider… | Xomed, Inc. | 1999 | — |
| +1 | K040239 | Supraflow Console | Neomedix Corp. | 2004 | 1 |
| +2 | K080845 | Orwell Fluid Collection and Disposal System | Cardinalhealth | 2008 | — |
| +3 | K090759 | Biodrain Streamway Fluid Management System | Biodrain Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 BTA? 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 BTA device
- #1 K222547 Electric nasal aspiratorscore 20.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K973268 | Microaire Power Aspiration Device Pad SystemSummary page 2…ollowing predicate devices that have been cleared for general removal of fluid and loose tissue: Powered Aspiration System MicroAire “Powered Aspiration Device” PAD-100 K973268 (MicroAire Surgical Instruments) Aspiration Cannulas Various aspiration cannulas K832520 (Wells Johnson Company) The predicate… | 1997 |
| * | K832520 | Suction TipsSummary page 2…issue: Powered Aspiration System MicroAire “Powered Aspiration Device” PAD-100 K973268 (MicroAire Surgical Instruments) Aspiration Cannulas Various aspiration cannulas K832520 (Wells Johnson Company) The predicate systems described above have also been cleared for the removal of tissue and fluids in ge… | 1983 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040239 | Supraflow Console | 2004 | 2 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K040239 (Neomedix Corp., 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All BTA devicesBTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTA
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · BTA
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTA
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTA
13in 2025
MAUDE reports naming product code BTA, 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 | — | 1 | 13 |
| 2008 | 3 | 135 | 3 | 5 |
| 2009 | 2 | — | 0 | 14 |
| 2010 | 2 | — | 3 | 178 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 3 | 45 | 0 | 18 |
| 2014 | 3 | 91 | 0 | 399 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 149 | 0 | 25 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 4 | 125 | 0 | 17 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 1 | 9 |
| 2022 | 3 | 58 | 0 | 7 |
| 2023 | 4 | 265 | 0 | 8 |
| 2024 | 5 | 131 | 0 | 13 |
| 2025 | 6 | 87 | 0 | 13 |
| 2026 | 7 | 89 | 0 | — |
What is it indicated for?
The Xomed XPS Tissue Aspiration System is intended for the removal of tissue and
fluids from the body during general surgical procedures.
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/K984363 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984363: XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984363
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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