510(k) · Cleared
ClearedPioneer U601 Series Aspirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merits Health Products Co., Ltd. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Nov 4, 2005 after a 39-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 4, 2005
- Review
- 39 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK052650 Pioneer U601 Series AspiratorMerits Health Products Co., Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK071607 ASA01 Heavy Duty Suction PumpZhongshan A&J Medical Equipment Co., Ltd. · 2007
Most influential descendants
Showing 1 of 1 · See all- K071607ASA01 Heavy Duty Suction PumpZhongshan A&J Medical Equipment Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052650 | Pioneer U601 Series Aspirator | Merits Health Products Co., Ltd. | 2005 | — |
| +1 | K071607 | ASA01 Heavy Duty Suction Pump | Zhongshan A&J Medical Equipment Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (1)
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 |
|---|---|---|---|
| * | — | THOMAS INDUSTRIES MEDI Pump Aspirator Model 1135 Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071607 | ASA01 Heavy Duty Suction Pump | 2007 | 0 |
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, K071607 (Zhongshan A&J Medical Equipment Co., Ltd., 2007) has gone furthest, with 0 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 | — |
What is it indicated for?
The Merits Pioneer U601 Series Aspirator is to be used to remove bodily fluids from the patients' airway or respiratory support system. It is for use on the order of a physician only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052650: Pioneer U601 Series Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052650
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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