510(k) · Cleared
Recalled · 2008Medela Vario 8/18/CI Secretion & Surgical Aspirator
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 Jun 21, 2006 as substantially equivalent to K983552 (Medela, Inc., 1999) and 1 other predicate after a 51-day review. Its family tree reaches back 2 generations to 1994. 85 later devices descend from it. It has been recalled once.
- Decided
- Jun 21, 2006
- Review
- 51 days
- Class
- Class II
- Product code
- BTA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933902 (1994). 4 ancestors in all. 85 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK933902 Moblvac IiiAeros Instruments, Inc. · 1994 · Recalled
- 1 generation backK043544 Medela Dominant 35 C/I Secretion and Surgical AspiratorMedela AG · 2005
- This deviceK061205 Medela Vario 8/18/CI Secretion & Surgical AspiratorMedela AG · 2006
- Descendant · cites it directly · 75 of its ownK080357 Medela Invia Wound TherapyMedela AG · 2008 · Recalled
- Descendant · 2 generations on · 56 of its ownK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 25 of its ownK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- Descendant · 4 generations on · 23 of its ownK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K080357Medela Invia Wound TherapyMedela AG · 2008 · cites it directly75descendants
- K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · 2 generations on56descendants
- K111170PICOSmith & Nephew, Inc. · 2011 · 3 generations on26descendants
- K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012 · 3 generations on25descendants
- K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933902 | Moblvac Iii | Aeros Instruments, Inc. | 1994 | 1 |
| −1 | K043544 | Medela Dominant 35 C/I Secretion and Surgical Aspirator | Medela AG | 2005 | — |
| 0 (this device) | K061205 | Medela Vario 8/18/CI Secretion & Surgical Aspirator | Medela AG | 2006 | — |
| +1 | K080357 | Medela Invia Wound Therapy | Medela AG | 2008 | 1 |
| +2 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| +3 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| +3 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| +4 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 9 | 0 |
| 2017 | 8 | 0 |
| 2018 | 9 | 0 |
| 2019 | 8 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K983552 | Basic, Median, Dominant, and VarioSummary page 1…CFR 878.4780 Product Code: BTA 3 Name of the predicate Device(s) * Medelat Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. K983552 * Medela ® Dominant 35 c/i, by Medela AG K043544 E-510k_SummaryVario.doc 2006-04-18… | 1999 |
| * | K043544 | Medela Dominant 35 C/I Secretion and Surgical AspiratorSummary page 1…me of the predicate Device(s) * Medelat Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. K983552 * Medela ® Dominant 35 c/i, by Medela AG K043544 E-510k_SummaryVario.doc 2006-04-18 Section E -1 of 3 Applicant:… | 2005 |
What descends from it? (85)
See all 855 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 25, 2008 | Not classified | Z-2168-2008 | Employee error | The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela Vario 18 Vacuum Pumps were provided with an incorrect… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 10.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K080357 (Medela AG, 2008) has gone furthest, with 75 descendants of its own.
- 8 other devices also cite its predicate K983552.
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 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 patients bedside. Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal and…
Read the full statement (111 words)
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 patients bedside.
Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning
procedures including nasopharyngeal, tracheal, surgical, gastrointestinal and thoracic
drainage (in combination with a water seal or dry seal chest drain) in either "constant"
or "intermittent" mode. Especially for thoracic drainage the Medela Vario 8 is indicated
in situations such as pneumothorax, after surgery (post operative), thorax injury,
pleura effusion, pleuryempyem or other related conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061205 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061205: Medela Vario 8/18/CI Secretion & Surgical Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061205
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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