510(k) · Cleared
ClearedTacvac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Athena Gtx · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Jan 28, 2016 as substantially equivalent to K041154 (Sscor, 2004) after a 58-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it.
- Decided
- Jan 28, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K840110 (1984). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K251101AIRO Suction Unit (AIRO-01)Cro, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K840110 | Laerdal Suction Unit | Laerdal Medical Corp. | 1984 | — |
| −1 | K041154 | S-Scort...JR Quickdraw, Model 2400 | Sscor | 2004 | — |
| 0 (this device) | K153459 | Tacvac | Athena Gtx | 2016 | — |
| +1 | K251101 | AIRO Suction Unit (AIRO-01) | Cro, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K041154 | S-Scort...JR Quickdraw, Model 2400Summary page 4…n Pump Device Class: Class II Basis for Submission: New Device Legally Marketed (Predicate) Device: S-SCORT... Jr® Quickdraw, Model 2400, (K041154) Device Description: The TACVAC™ portable battery powered suction device is designed for the same application and intended use… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251101 | AIRO Suction Unit (AIRO-01) | 2025 | 0 |
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 32 years and passes through 3 companies; a new generation was cleared every 20.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K251101 (Cro, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K041154.
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. 2016, this device’s year, is highlighted.
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 TACVAC™ portable battery powered suction device is intended to provide a battery powered medical suction source to clear bodily fluids and particulate matter from a patient. The primary intended use is to clear the airway by removing bodily fluids (including blood, saliva, mucous, vomitus or other aspirant) and particulate matter (less than 0.100"/2.50mm in diameter). The typical use environment is a pre-hospital in the field setting, transport, hospital and other healthcare applications by trained health care providers (EMTs, nurses, doctors, first responders, etc.). The patient population includes adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153459 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153459: Tacvac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153459
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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