510(k) · Cleared
ClearedAIRO Suction Unit (AIRO-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cro, LLC · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Apr 26, 2025 as substantially equivalent to K041154 (Sscor, 2004) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Apr 26, 2025
- Review
- 15 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K840110 (1984). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K840110 | Laerdal Suction Unit | Laerdal Medical Corp. | 1984 | — |
| −2 | K041154 | S-Scort...JR Quickdraw, Model 2400 | Sscor | 2004 | — |
| −1 | K153459 | Tacvac | Athena Gtx | 2016 | — |
| 0 (this device) | 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 |
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? (2)
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 5…ode(s) BTA Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name Product Code K041154 S-SCORT...JR QUICKDRAW, MODEL 2400 BTA Reference # Reference Trade Name… | 2004 |
| * | K153459 | TacvacSummary page 5…uct Code K041154 S-SCORT...JR QUICKDRAW, MODEL 2400 BTA Reference # Reference Trade Name Product Code K153459 TACVAC BTA Device Description Summary 21 CFR 807.92(a)(4) The AIRO Suction… | 2016 |
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 41 years and passes through 4 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 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. 2025, 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 AIRO Suction Unit, Model AIRO-01, is a portable, battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251101 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251101: AIRO Suction Unit (AIRO-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251101
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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