510(k) · Cleared
ClearedThorax-Klex Chest Drainage Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KDQ Bottle, Collection, Vacuum
Cleared on Mar 29, 1983 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Mar 29, 1983
- Review
- 25 days
- Class
- Class II
- Product code
- KDQ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK830671 Thorax-Klex Chest Drainage UnitC.R. Bard, Inc. · 1983
- Descendant · cites it directly · 5 of its ownK963850 Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion…Deknatel, Inc. · 1997
- Descendant · cites it directly · 5 of its ownK962856 Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model…Deknatel, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 4 of its ownK031554 S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion…Genzyme Biosurgery · 2003
- Descendant · 2 generations on · 3 of its ownK120953 Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemTlelflex Medical, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK130043 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K963850Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemDeknatel, Inc. · 1997 · cites it directly5descendants
- K962856Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…Deknatel, Inc. · 1996 · cites it directly5descendants
- K031554S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemGenzyme Biosurgery · 2003 · 2 generations on4descendants
- K120953Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemTlelflex Medical, Inc. · 2012 · 2 generations on3descendants
- K130043Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc. · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830671 | Thorax-Klex Chest Drainage Unit | C.R. Bard, Inc. | 1983 | — |
| +1 | K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System | Deknatel, Inc. | 1997 | — |
| +1 | K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200… | Deknatel, Inc. | 1996 | 1 |
| +2 | K031554 | S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System | Genzyme Biosurgery | 2003 | — |
| +2 | K120953 | Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System | Tlelflex Medical, Inc. | 2012 | — |
| +3 | K130043 | Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System | Teleflexmedical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KDQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System | 1997 | 5 |
| K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100… | 1996 | 5 |
| K963098 | Pleur-Evac Shara Plus Model S-2150/Continuous Reinfusion Autotransfusion System (S-100) | 1996 | 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?
- Of its descendants, K963850 (Deknatel, Inc., 1997) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KDQ devicesKDQ Bottle, Collection, Vacuum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDQ
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · KDQ
Too few KDQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KDQ
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KDQ
49in 2025
MAUDE reports naming product code KDQ, 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 | 0 | — | 0 | 48 |
| 2008 | 1 | — | 0 | 67 |
| 2009 | 0 | — | 2 | 165 |
| 2010 | 0 | — | 1 | 50 |
| 2011 | 0 | — | 0 | 40 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 2 | 43 |
| 2015 | 0 | — | 1 (1) | 34 |
| 2016 | 0 | — | 1 | 77 |
| 2017 | 0 | — | 0 | 53 |
| 2018 | 0 | — | 0 | 45 |
| 2019 | 0 | — | 1 | 57 |
| 2020 | 0 | — | 0 | 110 |
| 2021 | 0 | — | 1 | 110 |
| 2022 | 0 | — | 1 | 118 |
| 2023 | 0 | — | 1 | 92 |
| 2024 | 0 | — | 0 | 164 |
| 2025 | 0 | — | 0 | 49 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K830671 · printed Nov 3, 2026
Cite this page
510(k) Report. “K830671: Thorax-Klex Chest Drainage Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K830671
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026