510(k) · Cleared
ClearedLaerdal Suction Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laerdal Medical Corp. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Mar 12, 1984 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Mar 12, 1984
- Review
- 62 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK840110 Laerdal Suction UnitLaerdal Medical Corp. · 1984
- 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
- Descendant · cites it directly · 0 of its ownK993668 Laerdal Suction Unit,(4000) Model 78 00 20Laerdal Medical A/S · 1999
- Descendant · cites it directly · 0 of its ownK971107 Alexander Manufacturing CO. Rechargeable Battery Part Number STR5Alexander Mfg. Co. · 1997
Most influential descendants
Showing 5 of 5 · See all- K041154S-Scort...JR Quickdraw, Model 2400Sscor · 2004 · cites it directly2descendants
- K153459TacvacAthena Gtx · 2016 · 2 generations on1descendant
- K251101AIRO Suction Unit (AIRO-01)Cro, LLC · 2025 · 2 generations on0descendants
- K993668Laerdal Suction Unit,(4000) Model 78 00 20Laerdal Medical A/S · 1999 · cites it directly0descendants
- K971107Alexander Manufacturing CO. Rechargeable Battery Part Number STR5Alexander Mfg. Co. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K840110 | Laerdal Suction Unit | Laerdal Medical Corp. | 1984 | — |
| +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 | — |
| +1 | K993668 | Laerdal Suction Unit,(4000) Model 78 00 20 | Laerdal Medical A/S | 1999 | — |
| +1 | K971107 | Alexander Manufacturing CO. Rechargeable Battery Part Number STR5 | Alexander Mfg. Co. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 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? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- 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/K840110 · printed Nov 5, 2026
Cite this page
510(k) Report. “K840110: Laerdal Suction Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K840110
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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