510(k) · Cleared
ClearedSmartsuction Solo Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corp. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Oct 4, 2006 as substantially equivalent to K052626 (Haemonetics Corp., 2005) after a 15-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Oct 4, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021368 (2002). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K052626 | Smartsuction Harmony DeviceSummary page 1…Powered Suction Device Classification Name: AC Powered Suction Pump Predicate Device The predicate device is the SmartSuction HARMONY TM device, cleared under K052626 in October 2005. Description Powered suction pumps are described in FDA regulation, 21 CFR 878.4780, as: "A powered suction pum… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
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 SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician. The SmartSuction Solo device is not intended for endotracheal suction. The SmartSuction Solo device automatically…
Read the full statement (153 words)
The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician.
The SmartSuction Solo device is not intended for endotracheal suction. The SmartSuction Solo device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use SmartSuction Solo device as a suction source in any procedure where 150 mmHg of suction could damage underlying tissue.
This device is intended for use by trained personnel under the direction of a physician. The attending physician is responsible for the proper use of these devices. Therefore, the device is to be used as a prescription medical device, which is indicated in the labeling as "Rx only".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062801: Smartsuction Solo Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062801
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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