510(k) · Cleared
ClearedMedela Thopaz, Model 200 0288
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 Jul 23, 2008 as substantially equivalent to K061205 (Medela AG, 2006) and 1 other predicate after a 176-day review. Its family tree reaches back 3 generations to 1994. 5 later devices descend from it.
- Decided
- Jul 23, 2008
- Review
- 176 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933902 (1994). 5 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK933902 Moblvac IiiAeros Instruments, Inc. · 1994 · Recalled
- 2 generations backK043544 Medela Dominant 35 C/I Secretion and Surgical AspiratorMedela AG · 2005
- 1 generation backK061205 Medela Vario 8/18/CI Secretion & Surgical AspiratorMedela AG · 2006 · Recalled
- This deviceK080212 Medela Thopaz, Model 200 0288Medela AG · 2008
- Descendant · cites it directly · 2 of its ownK130210 Medela ThopazMedela AG · 2013
- Descendant · 2 generations on · 1 of its ownK141553 Medela Thopaz+Medela AG · 2014
- Descendant · cites it directly · 1 of its ownK103042 Atmos E 201 Thorax and Atmos S 201 ThoraxAtmos, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK241799 ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml…Atmos Medizintechnik GmbH & Co. KG · 2025
- Descendant · 3 generations on · 0 of its ownK181667 Thoraguard SystemCentese, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K130210Medela ThopazMedela AG · 2013 · cites it directly2descendants
- K141553Medela Thopaz+Medela AG · 2014 · 2 generations on1descendant
- K103042Atmos E 201 Thorax and Atmos S 201 ThoraxAtmos, Inc. · 2011 · cites it directly1descendant
- K241799ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system…Atmos Medizintechnik GmbH & Co. KG · 2025 · 2 generations on0descendants
- K181667Thoraguard SystemCentese, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933902 | Moblvac Iii | Aeros Instruments, Inc. | 1994 | 1 |
| −2 | K043544 | Medela Dominant 35 C/I Secretion and Surgical Aspirator | Medela AG | 2005 | — |
| −1 | K061205 | Medela Vario 8/18/CI Secretion & Surgical Aspirator | Medela AG | 2006 | 1 |
| 0 (this device) | K080212 | Medela Thopaz, Model 200 0288 | Medela AG | 2008 | — |
| +1 | K130210 | Medela Thopaz | Medela AG | 2013 | — |
| +2 | K141553 | Medela Thopaz+ | Medela AG | 2014 | — |
| +1 | K103042 | Atmos E 201 Thorax and Atmos S 201 Thorax | Atmos, Inc. | 2011 | — |
| +2 | K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose… | Atmos Medizintechnik GmbH & Co. KG | 2025 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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 1…ied Class II, per 21 CFR 878.4780 Product Code: BTA 3 Name of the predicate Device(s) * Medela® Vario 8/18/ci Suction Pumps, by Medela Inc. K061205 · Medela® Dominant 35 c/i Suction Pump, by Medela AG K043544 E_510k_SummaryTHOPAZ.doc 2008-01-24… | 2006 |
| * | K043544 | Medela Dominant 35 C/I Secretion and Surgical AspiratorSummary page 1…3 Name of the predicate Device(s) * Medela® Vario 8/18/ci Suction Pumps, by Medela Inc. K061205 · Medela® Dominant 35 c/i Suction Pump, by Medela AG K043544 E_510k_SummaryTHOPAZ.doc 2008-01-24 Section E - 1 of 3… | 2005 |
What descends from it? (5)
2 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)
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 14 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K130210 (Medela AG, 2013) has gone furthest, with 2 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. 2008, 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 indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery).
Generally the Medela THOPAZ is intended to be used in all situations where chest drains are applied - especially for thoracic drainage and 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/K080212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080212: Medela Thopaz, Model 200 0288.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080212
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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