510(k) · Cleared
ClearedThoraguard System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centese, Inc. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Nov 29, 2018 as substantially equivalent to K141553 (Medela AG, 2014) after a 157-day review. Its family tree reaches back 6 generations to 1994. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 29, 2018
- Review
- 157 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933902 (1994). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK933902 Moblvac IiiAeros Instruments, Inc. · 1994 · Recalled
- 5 generations backK043544 Medela Dominant 35 C/I Secretion and Surgical AspiratorMedela AG · 2005
- 4 generations backK061205 Medela Vario 8/18/CI Secretion & Surgical AspiratorMedela AG · 2006 · Recalled
- 3 generations backK080212 Medela Thopaz, Model 200 0288Medela AG · 2008
- 2 generations backK130210 Medela ThopazMedela AG · 2013
- 1 generation backK141553 Medela Thopaz+Medela AG · 2014
- This deviceK181667 Thoraguard SystemCentese, Inc. · 2018
Class I recalls in this family
- K043140 Express and Oasis Chest Drain3 generations back · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933902 | Moblvac Iii | Aeros Instruments, Inc. | 1994 | 1 |
| −5 | K043544 | Medela Dominant 35 C/I Secretion and Surgical Aspirator | Medela AG | 2005 | — |
| −4 | K061205 | Medela Vario 8/18/CI Secretion & Surgical Aspirator | Medela AG | 2006 | 1 |
| −3 | K080212 | Medela Thopaz, Model 200 0288 | Medela AG | 2008 | — |
| −2 | K130210 | Medela Thopaz | Medela AG | 2013 | — |
| −1 | K141553 | Medela Thopaz+ | Medela AG | 2014 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K141553 | Medela Thopaz+Summary page 4…ion Name: Pump, Portable, Aspiration (Manual or Powered) [21 CFR 878.4780] Regulatory Class: II Product Code: BTA 3. Predicate Device Thopaz+ Suction Pump by Medela AG (K141553) 4. Device Description The Thoraguard Surgical Drainage System is an AC/DC powered suction pump designed for the aspiration and… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
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. 2018, 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 Thoraguard System is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Thoraguard System 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 Thoraguard System is intended for use on patients in appropriate care settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181667: Thoraguard System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181667
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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