510(k) · Cleared
ClearedAtmos E 201 Thorax and Atmos S 201 Thorax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atmos, Inc. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Apr 15, 2011 as substantially equivalent to K080212 (Medela AG, 2008) and 1 other predicate after a 183-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Apr 15, 2011
- Review
- 183 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. 1 later device descends from it, 1 citing it directly.
- 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 deviceK103042 Atmos E 201 Thorax and Atmos S 201 ThoraxAtmos, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK241799 ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml…Atmos Medizintechnik GmbH & Co. KG · 2025
Most influential descendants
Showing 1 of 1 · See all- K241799ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system…Atmos Medizintechnik GmbH & Co. KG · 2025 · cites it directly0descendants
View 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) | K103042 | Atmos E 201 Thorax and Atmos S 201 Thorax | Atmos, Inc. | 2011 | — |
| +1 | K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose… | Atmos Medizintechnik GmbH & Co. KG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K080212 | Medela Thopaz, Model 200 0288Summary page 1…BATTERY) 878.4780, Class 11 Product Code: BTA Predicate Devices: 21 CFR 807. 92(a)(3) 510(k) Number K080212 Device Name Medela THOPAZ Applicant Medela… | 2008 |
| * | K043582 | Ocean Chest DrainSummary page 1…Substantially equivalent (SE) Classification Advisory Committee General & Plastic Surgery 510(k) Number K043582 Device Name Ocean Chest Drain Applicant Atr… | 2005 |
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 |
|---|---|---|---|
| K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system… | 2025 | 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 17 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K241799 (Atmos Medizintechnik GmbH & Co. KG, 2025) has gone furthest, with 0 descendants 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. 2011, 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 ATMOS E 201 Thorax and the ATMOS S 201 Thorax are indicated for
aspiration and removal of surgical fluids, tissue, gases, bodily fluids or
infectious material from a patient's respiratory support system after surgery.
The general indication of the ATMOS S 201 Thorax and the ATMOS E 201
Thorax is thoracic drainage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103042: Atmos E 201 Thorax and Atmos S 201 Thorax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103042
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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