510(k) · Cleared
ClearedMedi-Pump Aspirator, Model 1615
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thomas Industries · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Jun 1, 2004 as substantially equivalent to K944399 (Thomas Industries, 1995) after a 25-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Jun 1, 2004
- Review
- 25 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944399 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK944399 Medi-PumpThomas Industries · 1995
- This deviceK041199 Medi-Pump Aspirator, Model 1615Thomas Industries · 2004
- Descendant · cites it directly · 3 of its ownK112421 Emg Suction UnitEmg Technology Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK182950 Acare Suction UnitAcare Technology Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK250964 Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK140031 Suction PumpDing Hwa Co., Ltd. · 2014
Most influential descendants
Showing 4 of 4 · See all- K112421Emg Suction UnitEmg Technology Co., Ltd. · 2011 · cites it directly3descendants
- K182950Acare Suction UnitAcare Technology Co., Ltd. · 2019 · 2 generations on1descendant
- K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2026 · 3 generations on0descendants
- K140031Suction PumpDing Hwa Co., Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944399 | Medi-Pump | Thomas Industries | 1995 | — |
| 0 (this device) | K041199 | Medi-Pump Aspirator, Model 1615 | Thomas Industries | 2004 | — |
| +1 | K112421 | Emg Suction Unit | Emg Technology Co., Ltd. | 2011 | — |
| +2 | K182950 | Acare Suction Unit | Acare Technology Co., Ltd. | 2019 | — |
| +3 | K250964 | Protable Phlegm Suction Unit (JMA D01) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K140031 | Suction Pump | Ding Hwa Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K944399 | Medi-PumpSummary page 1…Classification: LI Product Code: BTA - Pump, Portable, Aspiration Predicate Device: K944399 - Medi-Pump Model 1210 Aspirator Device Description: The Medi-Pump is a portable AC powered home use suction p… | 1995 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112421 | Emg Suction Unit | 2011 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K112421 (Emg Technology Co., Ltd., 2011) has gone furthest, with 3 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 Medi-Pump 1615 aspirator is intended to be used to remove bodily fluids from a patient's airway or respiratory system. The aspirator is a prescription device intended for use in the home by professional home healthcare providers and non-professional caregivers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041199: Medi-Pump Aspirator, Model 1615.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041199
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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