510(k) · Cleared
ClearedLaerdal Suction Unit,(4000) Model 78 00 20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laerdal Medical A/S · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Dec 20, 1999 as substantially equivalent to K840110 (Laerdal Medical Corp., 1984) and 2 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Dec 20, 1999
- Review
- 49 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K840110 (1984). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK840110 Laerdal Suction UnitLaerdal Medical Corp. · 1984
- This deviceK993668 Laerdal Suction Unit,(4000) Model 78 00 20Laerdal Medical A/S · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840110 | Laerdal Suction Unit | Laerdal Medical Corp. | 1984 | — |
| 0 (this device) | K993668 | Laerdal Suction Unit,(4000) Model 78 00 20 | Laerdal Medical A/S | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 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? (4)
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 |
|---|---|---|---|
| * | K840110 | Laerdal Suction UnitSummary page 1…Suction Pump (21 CFR, 878, 4780) Predicate device: Laerdal™ Suction Unit (LSU); Pre-amendments device Laerdal™ Suction Unit (LSU); Post-amendments update of above unit K840110 — May, 1984 Laerdal™ Compact Suction Unit (LCSU) K872094 — October, 1987 Laerdal™ Suction Unit 2000 (LSU200) a.k.a. Laerdal™ Pr… | 1984 |
| * | K872094 | Vacu-AideSummary page 1…l™ Suction Unit (LSU); Pre-amendments device Laerdal™ Suction Unit (LSU); Post-amendments update of above unit K840110 — May, 1984 Laerdal™ Compact Suction Unit (LCSU) K872094 — October, 1987 Laerdal™ Suction Unit 2000 (LSU200) a.k.a. Laerdal™ Premier Suction Unit (LPSU), K950698 — May, 1995 General de… | 1987 |
| * | K950698 | Lsu 2000 Portable Suction UnitSummary page 1…unit K840110 — May, 1984 Laerdal™ Compact Suction Unit (LCSU) K872094 — October, 1987 Laerdal™ Suction Unit 2000 (LSU200) a.k.a. Laerdal™ Premier Suction Unit (LPSU), K950698 — May, 1995 General device description: The pre-amendment (original) Laerdal™ Suction Unit (LSU) was developed in 1969. It consi… | 1995 |
| * | — | Laerdal™ Suction Unit (LSU); Pre-amendments device Named without a submission number |
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?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K840110.
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?
Indications for use are identical for the predicate products cited, and also more than 20 others sold in the US market, i.e., to reinove obstructing secretions, blood or vomits from a patient’s airway, to keep air passages to lungs open to allow ventilation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993668 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993668: Laerdal Suction Unit,(4000) Model 78 00 20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993668
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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