510(k) · Cleared
ClearedS-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Biosurgery · CAC Apparatus, Autotransfusion
Cleared on Jul 25, 2003 as substantially equivalent to K963850 (Deknatel, Inc., 1997) after a 67-day review. Its family tree reaches back 2 generations to 1980. 4 later devices descend from it.
- Decided
- Jul 25, 2003
- Review
- 67 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K801043 (1980). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK801043 E-Vax Chest Drainage SystemCardio Surgical Concepts, Inc. · 1980
- 1 generation backK963850 Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion…Deknatel, Inc. · 1997
- This deviceK031554 S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion…Genzyme Biosurgery · 2003
- Descendant · cites it directly · 3 of its ownK120953 Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemTlelflex Medical, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK130043 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK140205 Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion…Teleflexmedical, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 0 of its ownK193361 ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K120953Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemTlelflex Medical, Inc. · 2012 · cites it directly3descendants
- K130043Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc. · 2013 · 2 generations on2descendants
- K140205Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion SystemTeleflexmedical, Inc. · 2014 · 3 generations on1descendant
- K193361ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801043 | E-Vax Chest Drainage System | Cardio Surgical Concepts, Inc. | 1980 | — |
| −1 | K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System | Deknatel, Inc. | 1997 | — |
| 0 (this device) | K031554 | S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System | Genzyme Biosurgery | 2003 | — |
| +1 | K120953 | Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System | Tlelflex Medical, Inc. | 2012 | — |
| +2 | K130043 | Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System | Teleflexmedical, Inc. | 2013 | — |
| +3 | K140205 | Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System | Teleflexmedical, Inc. | 2014 | 1 |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemSummary page 2…ion is similar in intended use, materials and performance characteristics of the currently marketed Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System (#K963850). The determination of substantial equivalence for this device was based on a detailed device description, performance testing a… | 1997 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120953 | Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System | 2012 | 3 |
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 23 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K120953 (Tlelflex Medical, Inc., 2012) has gone furthest, with 3 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.
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?
Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is indicated for use:
AUTOTRANSFUSION
1) for the collection of autologous blood from the patient’s pleural cavity or mediastinal area for reinfusion purposes in trauma and post operative situations.
CHEST DRAINAGE
2) to evacuate air and/or fluid from the chest cavity or mediastinum
3) to help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum
4) to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion to restore normal breathing dynamics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031554: S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion 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/K031554
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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