510(k) · Cleared
ClearedMedela Thopaz
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 Mar 15, 2013 as substantially equivalent to K080212 (Medela AG, 2008) and 1 other predicate after a 45-day review. Its family tree reaches back 4 generations to 1994. 1 of the 10 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Mar 15, 2013
- Review
- 45 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933902 (1994). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK933902 Moblvac IiiAeros Instruments, Inc. · 1994 · Recalled
- 3 generations backK043544 Medela Dominant 35 C/I Secretion and Surgical AspiratorMedela AG · 2005
- 2 generations backK061205 Medela Vario 8/18/CI Secretion & Surgical AspiratorMedela AG · 2006 · Recalled
- 1 generation backK080212 Medela Thopaz, Model 200 0288Medela AG · 2008
- This deviceK130210 Medela ThopazMedela AG · 2013
- Descendant · cites it directly · 1 of its ownK141553 Medela Thopaz+Medela AG · 2014
- Descendant · 2 generations on · 0 of its ownK181667 Thoraguard SystemCentese, Inc. · 2018
Class I recalls in this family
- K043140 Express and Oasis Chest Draindirect predicate · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933902 | Moblvac Iii | Aeros Instruments, Inc. | 1994 | 1 |
| −3 | K043544 | Medela Dominant 35 C/I Secretion and Surgical Aspirator | Medela AG | 2005 | — |
| −2 | K061205 | Medela Vario 8/18/CI Secretion & Surgical Aspirator | Medela AG | 2006 | 1 |
| −1 | K080212 | Medela Thopaz, Model 200 0288 | Medela AG | 2008 | — |
| 0 (this device) | K130210 | Medela Thopaz | Medela AG | 2013 | — |
| +1 | K141553 | Medela Thopaz+ | Medela AG | 2014 | — |
| +2 | K181667 | Thoraguard System | Centese, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K080212 | Medela Thopaz, Model 200 0288Summary page 1…BLE, ASPIRATION (MANUAL OR POWERED) Classified Class 11,per 21 CIFR 878.4780 Product Code: BTA 3., Name of the predicate Device(s) - Medela® THOPAZ, K080212 -OasiSTM Chest Drain, K043140 Medelaa®THOPAZ 510(k)… | 2008 |
| * | K043140 | Express and Oasis Chest DrainSummary page 1…) Classified Class 11,per 21 CIFR 878.4780 Product Code: BTA 3., Name of the predicate Device(s) - Medela® THOPAZ, K080212 -OasiSTM Chest Drain, K043140 Medelaa®THOPAZ 510(k) Summary… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141553 | Medela Thopaz+ | 2014 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K043140Express and Oasis Chest DrainAtrium Medical Corp. · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K141553 (Medela AG, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K080212.
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. 2013, 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® THOPAZ Suction Pump is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Medela® THOPAZ Suction Pump is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. The Medela® THOPAZ Suction Pump is intended for use on patients in appropriate care settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130210: Medela Thopaz.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130210
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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