510(k) · Cleared
Recalled · Class II · 2016Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · CAC Apparatus, Autotransfusion
Cleared on Oct 23, 2014 as substantially equivalent to K130043 (Teleflexmedical, Inc., 2013) after a 269-day review. Its family tree reaches back 5 generations to 1980. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 23, 2014
- Review
- 269 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K801043 (1980). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK801043 E-Vax Chest Drainage SystemCardio Surgical Concepts, Inc. · 1980
- 4 generations backK963850 Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion…Deknatel, Inc. · 1997
- 3 generations backK031554 S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion…Genzyme Biosurgery · 2003
- 2 generations backK120953 Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemTlelflex Medical, Inc. · 2012
- 1 generation backK130043 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc. · 2013
- This deviceK140205 Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion…Teleflexmedical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK193361 ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K193361ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801043 | E-Vax Chest Drainage System | Cardio Surgical Concepts, Inc. | 1980 | — |
| −4 | K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System | Deknatel, Inc. | 1997 | — |
| −3 | 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 | — |
| −1 | K130043 | Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System | Teleflexmedical, Inc. | 2013 | — |
| 0 (this device) | K140205 | Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System | Teleflexmedical, Inc. | 2014 | — |
| +1 | K193361 | ProCell Surgical Sponge-Blood Recovery Unit | Procell Surgical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 CAC? 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 CAC device
- #1 K240426 Aventus Clot Management Systemscore 11.2 · 4 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 |
|---|---|---|---|
| * | K130043 | Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemSummary page 5…510(k) No. Date Cleared S-1150-08LF Pleur-evac Sahara® Plus Continuous Teleflex Medical K130043 February 12, 2013 Reinfusion Autoransfusion System I. Comparison to Predicate Devices… | 2013 |
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 |
|---|---|---|---|
| K193361 | ProCell Surgical Sponge-Blood Recovery Unit | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 30, 2016 | Class II | Z-1582-2016 | Error in labeling | The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K193361 (Procell Surgical, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · CAC
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAC
91in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAC
7in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CAC
128in 2025
MAUDE reports naming product code CAC, 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 | — | 1 | 35 |
| 2008 | 1 | — | 5 | 12 |
| 2009 | 0 | — | 25 | 68 |
| 2010 | 4 | 123 | 3 | 115 |
| 2011 | 2 | — | 3 | 939 |
| 2012 | 3 | 90 | 0 | 249 |
| 2013 | 1 | — | 9 | 153 |
| 2014 | 3 | 269 | 0 | 90 |
| 2015 | 0 | — | 0 | 87 |
| 2016 | 2 | — | 0 | 73 |
| 2017 | 1 | — | 2 | 88 |
| 2018 | 2 | — | 2 | 87 |
| 2019 | 1 | — | 23 | 64 |
| 2020 | 1 | — | 0 | 108 |
| 2021 | 4 | 155 | 0 | 73 |
| 2022 | 1 | — | 0 | 65 |
| 2023 | 2 | — | 7 (2) | 39 |
| 2024 | 3 | 91 | 0 | 129 |
| 2025 | 0 | — | 0 | 128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the collection of autologous blood from the patient’s pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations,
To evacuate air and/or fluid from the chest cavity or mediastinum,
To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum,
To help re-establish and maintain normal intra-thoracic pressure gradients,
To facilitate complete lung re-expansion to restore normal breathing dynamics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140205: Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140205
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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