510(k) · Cleared
Recalled · 2005S-Scort (R)Duet Model 2014 Portable Suction Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sscor · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Dec 22, 1994 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 1994
- Review
- 17 days
- Class
- Class II
- Product code
- BTA
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK945929 S-Scort (R)Duet Model 2014 Portable Suction PumpSscor · 1994
- Descendant · cites it directly · 2 of its ownK041154 S-Scort...JR Quickdraw, Model 2400Sscor · 2004
- Descendant · 2 generations on · 1 of its ownK153459 TacvacAthena Gtx · 2016
- Descendant · 2 generations on · 0 of its ownK251101 AIRO Suction Unit (AIRO-01)Cro, LLC · 2025
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 |
|---|---|---|---|---|---|
| 0 (this device) | K945929 | S-Scort (R)Duet Model 2014 Portable Suction Pump | Sscor | 1994 | — |
| +1 | K041154 | S-Scort...JR Quickdraw, Model 2400 | Sscor | 2004 | — |
| +2 | K153459 | Tacvac | Athena Gtx | 2016 | — |
| +2 | K251101 | AIRO Suction Unit (AIRO-01) | Cro, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K041154 | S-Scort...JR Quickdraw, Model 2400 | 2004 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2005 | Not classified | Z-0411-05 | Other | Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041154 (Sscor, 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 | — |
https://510kreport.com/device/K945929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945929: S-Scort (R)Duet Model 2014 Portable Suction Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945929
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026