510(k) · Cleared
Recalled · 2007Supraflow Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neomedix Corp. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Feb 17, 2004 as substantially equivalent to K981703 (Karl Storz Endoscopy, 1998) and 2 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1983. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 17, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- BTA
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K832520 (1983). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK832520 Suction TipsWells Johnson Co. · 1983
- 2 generations backK973268 Microaire Power Aspiration Device Pad SystemMicroaire Surgical Instruments, Inc. · 1997 · Recalled
- 1 generation backK984363 XPS Tissue Aspiration System, XPS Straightshot or Model 2000…Xomed, Inc. · 1999
- This deviceK040239 Supraflow ConsoleNeomedix Corp. · 2004
- Descendant · cites it directly · 1 of its ownK080845 Orwell Fluid Collection and Disposal SystemCardinalhealth · 2008
- Descendant · 2 generations on · 0 of its ownK090759 Biodrain Streamway Fluid Management SystemBiodrain Medical, Inc. · 2009
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 |
|---|---|---|---|---|---|
| −3 | K832520 | Suction Tips | Wells Johnson Co. | 1983 | — |
| −2 | K973268 | Microaire Power Aspiration Device Pad System | Microaire Surgical Instruments, Inc. | 1997 | 1 |
| −1 | K984363 | XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider… | Xomed, Inc. | 1999 | — |
| 0 (this device) | K040239 | Supraflow Console | Neomedix Corp. | 2004 | — |
| +1 | K080845 | Orwell Fluid Collection and Disposal System | Cardinalhealth | 2008 | — |
| +2 | 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 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K981703 | Ksea Unimat 45Summary page 1…eoMedix SupraFlow Console Model numbers 550014, 550019, 550020 are similar in indications, function and features to the following Devices: The Karl Storz KSEA Unimat 45 (K981703), the XOMED Tissue Aspiration System (K984363) and the Lysonix Aspiration Pump (K980454). Indications for Use The NeoMedix Supr… | 1998 |
| * | K984363 | XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider SystemSummary page 1…, 550019, 550020 are similar in indications, function and features to the following Devices: The Karl Storz KSEA Unimat 45 (K981703), the XOMED Tissue Aspiration System (K984363) and the Lysonix Aspiration Pump (K980454). Indications for Use The NeoMedix SupraFlow Console is to be used in general surgery… | 1999 |
| * | K980454 | Lysonix Aspiration PumpSummary page 1…s, function and features to the following Devices: The Karl Storz KSEA Unimat 45 (K981703), the XOMED Tissue Aspiration System (K984363) and the Lysonix Aspiration Pump (K980454). Indications for Use The NeoMedix SupraFlow Console is to be used in general surgery applications where aspiration of irrigati… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080845 | Orwell Fluid Collection and Disposal System | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2007 | Not classified | Z-0071-2008 | Nonconforming Material/Component | Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in… |
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 5.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K080845 (Cardinalhealth, 2008) has gone furthest, with 1 descendant 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 NeoMedix SupraFlow Console is an aspiration pump intended for use in general surgery applications where aspiration of irrigation and waste fluid from a surgical site is desired.
The device is not indicated for liposuction use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040239: Supraflow Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040239
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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