510(k) · Cleared
Recalled · Class II · 2016Microaire Power Aspiration Device Pad System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microaire Surgical Instruments, Inc. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Nov 26, 1997 as substantially equivalent to K832520 (Wells Johnson Co., 1983) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1983. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 26, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- BTA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832520 (1983). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK832520 Suction TipsWells Johnson Co. · 1983
- This deviceK973268 Microaire Power Aspiration Device Pad SystemMicroaire Surgical Instruments, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK984363 XPS Tissue Aspiration System, XPS Straightshot or Model 2000…Xomed, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK040239 Supraflow ConsoleNeomedix Corp. · 2004 · Recalled
- Descendant · 3 generations on · 1 of its ownK080845 Orwell Fluid Collection and Disposal SystemCardinalhealth · 2008
- Descendant · 4 generations on · 0 of its ownK090759 Biodrain Streamway Fluid Management SystemBiodrain Medical, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K984363XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider SystemXomed, Inc. · 1999 · cites it directly3descendants
- K040239Supraflow ConsoleNeomedix Corp. · 2004 · 2 generations on2descendants
- K080845Orwell Fluid Collection and Disposal SystemCardinalhealth · 2008 · 3 generations on1descendant
- K090759Biodrain Streamway Fluid Management SystemBiodrain Medical, Inc. · 2009 · 4 generations on0descendants
View 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) | K973268 | Microaire Power Aspiration Device Pad System | Microaire Surgical Instruments, Inc. | 1997 | — |
| +1 | K984363 | XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider… | Xomed, Inc. | 1999 | — |
| +2 | K040239 | Supraflow Console | Neomedix Corp. | 2004 | 1 |
| +3 | K080845 | Orwell Fluid Collection and Disposal System | Cardinalhealth | 2008 | — |
| +4 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K832520 | Suction TipsSummary page 1…general use, 21 CFR §878.4800 MicroAire believes the PAD™ System to be substantially equivalent in basic form and function to the following legally marketed devices: e K832520 Wells Johnson Suction Tips e KB861878 Byron Suction Tips The predicate devices are cannulae that are capable of being attached… | 1983 |
| * | K861878 | Byron Suction TipsSummary page 1…believes the PAD™ System to be substantially equivalent in basic form and function to the following legally marketed devices: e K832520 Wells Johnson Suction Tips e KB861878 Byron Suction Tips The predicate devices are cannulae that are capable of being attached to a suction source. These devices are… | 1986 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984363 | XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider System | 1999 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 8, 2016 | Class II | Z-1323-2016 | Component design/selection | Complaints that the cannula bent/broke during surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 MicroAire PAD System is indicated for the removal
of tissue or fluid 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/K973268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973268: Microaire Power Aspiration Device Pad System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973268
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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