510(k) · Cleared
ClearedVario 8/18/ci
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela AG · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on May 18, 2016 as substantially equivalent to K061205 (Medela AG, 2006) and 1 other predicate after a 149-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- May 18, 2016
- Review
- 149 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945062 (1995). 8 ancestors in all, the oldest K933902 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 2 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 1 generation backK061435 Medela Vario Suction PumpsMedela AG · 2006
- This deviceK153663 Vario 8/18/ciMedela AG · 2016
- Descendant · cites it directly · 0 of its ownK221676 ExsaltaDrw Medical · 2022
Most influential descendants
Showing 1 of 1 · See all- K221676ExsaltaDrw Medical · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −2 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −1 | K061435 | Medela Vario Suction Pumps | Medela AG | 2006 | — |
| 0 (this device) | K153663 | Vario 8/18/ci | Medela AG | 2016 | — |
| +1 | K221676 | Exsalta | Drw Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K061205 | Medela Vario 8/18/CI Secretion & Surgical AspiratorSummary page 5…TRADE NAME: Vario 8/18/ci COMMON/USUAL NAME: Powered Suction Pump CLASSIFICATION NAMES: 21 CFR 878.4780 Powered Suction Pump PRODUCT CODE: BTA PREDICATE DEVICE(S): K061205, K061435 Medela Vario 8/18/ci… | 2006 |
| * | K061435 | Medela Vario Suction PumpsSummary page 5…ME: Vario 8/18/ci COMMON/USUAL NAME: Powered Suction Pump CLASSIFICATION NAMES: 21 CFR 878.4780 Powered Suction Pump PRODUCT CODE: BTA PREDICATE DEVICE(S): K061205, K061435 Medela Vario 8/18/ci… | 2006 |
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 |
|---|---|---|---|
| K221676 | Exsalta | 2022 | 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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K221676 (Drw Medical, 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K061205.
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. 2016, 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 Medela Vario 8/18/ci Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient’s bed-side.
Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal in either "constant" or "intermittent" mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153663 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153663: Vario 8/18/ci.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153663
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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