510(k) · Cleared
Recalled · 2004Easygo Aspirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Medical, Inc. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Apr 1, 1998 after a 324-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 of the 34 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 1, 1998
- Review
- 324 days
- Class
- Class II
- Product code
- BTA
- Recalls
- 2
- Predicates
- 0
33 later devices descend from it, 3 citing it directly. 3 of the 34 devices in this family, counting this one, have a Class I recall.
- This deviceK971749 Easygo AspiratorPrecision Medical, Inc. · 1998
- Descendant · cites it directly · 18 of its ownK061133 Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SNovaspine, LLC · 2006
- Descendant · 2 generations on · 16 of its ownK062456 Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006
- Descendant · 3 generations on · 15 of its ownK112458 Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy…Medica-Rents Co., Ltd. · 2012
- Descendant · cites it directly · 12 of its ownK140179 Easy GO VacPrecision Medical, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 33 · See all- K061133Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SNovaspine, LLC · 2006 · cites it directly18descendants
- K062456Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006 · 2 generations on16descendants
- K112458Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy SystemMedica-Rents Co., Ltd. · 2012 · 3 generations on15descendants
- K140179Easy GO VacPrecision Medical, Inc. · 2014 · cites it directly12descendants
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971749 | Easygo Aspirator | Precision Medical, Inc. | 1998 | — |
| +1 | K061133 | Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S | Novaspine, LLC | 2006 | — |
| +2 | K062456 | Novaspine Powered Suction Pump Pro-1 | Novaspine, LLC | 2006 | — |
| +3 | K112458 | Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System | Medica-Rents Co., Ltd. | 2012 | — |
| +1 | K140179 | Easy GO Vac | Precision Medical, Inc. | 2014 | — |
| +2 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 1 |
| 2018 | 4 | 0 |
| 2019 | 3 | 1 |
| 2020 | 1 | 0 |
| 2021 | 3 | 1 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (33)
See all 333 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2004 | Not classified | Z-0307-05 | Other | Battery charger can be overcharged and overheat |
| Nov 9, 2004 | Not classified | Z-0308-05 | Other | Battery charger can be overcharged and overheat |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K061133 (Novaspine, LLC, 2006) has gone furthest, with 18 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 EasyGo Aspirator provides a portable battery powered medical vacuum source. The EasyGo Aspirator can also be powered by standard wall outlet with the use of an AC power adapter. It is intended for use in the homecare & hospital environment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971749 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971749: Easygo Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971749
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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