510(k) · Cleared
ClearedArdo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ardo Medical AG · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Jun 8, 2001 as substantially equivalent to K853917 (Egnell, Inc., 1985) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jun 8, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K853917 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK853917 Egnell Compact Suction PumpEgnell, Inc. · 1985
- This deviceK011601 Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator…Ardo Medical AG · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853917 | Egnell Compact Suction Pump | Egnell, Inc. | 1985 | — |
| 0 (this device) | K011601 | Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model… | Ardo Medical AG | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K853917 | Egnell Compact Suction PumpSummary page 1…, senator e Common Name: Suction Pump + Classification Name: Powered Suction Pump (per 21 CFR 878.4780) 5. Predicate Devices: * egnell compact suction pump by Ameda AG, K853917, November 25, 1985 * Dominant suction pump by Medela AG, K983552, January 7, 1999 6. Device Description: The Ardo Suction Pumps… | 1985 |
| * | K983552 | Basic, Median, Dominant, and VarioSummary page 1…red Suction Pump (per 21 CFR 878.4780) 5. Predicate Devices: * egnell compact suction pump by Ameda AG, K853917, November 25, 1985 * Dominant suction pump by Medela AG, K983552, January 7, 1999 6. Device Description: The Ardo Suction Pumps master and senator are high performance suction pumps with mainte… | 1999 |
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 2 ancestors has a recall.
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?
The Ardo Suction Pumps master and senator are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
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/K011601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011601: Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011601
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026