510(k) · Cleared
ClearedPleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tlelflex Medical, Inc. · CAC Apparatus, Autotransfusion
Cleared on Dec 10, 2012 as substantially equivalent to K031554 (Genzyme Biosurgery, 2003) and 1 other predicate after a 255-day review. Its family tree reaches back 3 generations to 1980. 3 later devices descend from it.
- Decided
- Dec 10, 2012
- Review
- 255 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K801043 (1980). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK801043 E-Vax Chest Drainage SystemCardio Surgical Concepts, Inc. · 1980
- 2 generations backK963850 Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion…Deknatel, Inc. · 1997
- 1 generation backK031554 S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion…Genzyme Biosurgery · 2003
- This deviceK120953 Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemTlelflex Medical, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK130043 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK140205 Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion…Teleflexmedical, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK193361 ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K130043Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc. · 2013 · cites it directly2descendants
- K140205Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion SystemTeleflexmedical, Inc. · 2014 · 2 generations on1descendant
- K193361ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801043 | E-Vax Chest Drainage System | Cardio Surgical Concepts, Inc. | 1980 | — |
| −2 | K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System | Deknatel, Inc. | 1997 | — |
| −1 | K031554 | S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System | Genzyme Biosurgery | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K140205 | Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System | Teleflexmedical, Inc. | 2014 | 1 |
| +3 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031554 | S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemSummary page 8…st results, the proposed Pleur-evac® Autotransfusion Systems are substantially equivalent in performance to the predicate devices cleared to market via 5I10(k) K(031554 and K962856. The modifications made to the proposed Pleur-evac® Autotransfusion Systems do not introduce any new issues of… | 2003 |
| * | K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…Summary page 3…ezmBisrey K315Juy2,03 Pleur-evac® Sahara Adult/Sahara Chest Drainage Deknatel DSP System Models S-I 100, S-1200, Worldwide K962856 September 10, 1996 S-2 100 and S-2200 with Model Incorporated S-100 AutotransfusionBag ____… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130043 | Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System | 2013 | 2 |
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 32 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K130043 (Teleflexmedical, Inc., 2013) has gone furthest, with 2 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. 2012, 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?
AUTOTRANSFUSION 1. For the collection of autologuous blood fiom the patient's pleural cavity or mediastinal area for reinfusion purposes in trauima and post-operative situations CHEST DRAINAGE 1. To evacuate air and/or fluid from the chest cavity or mediastinum 2. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. 3. To help re-establish and maintain normal intra-thoracic pressure gradients. 4. To facilitate…
Read the full statement (110 words)
AUTOTRANSFUSION
1. For the collection of autologuous blood fiom the patient's pleural cavity or mediastinal area for reinfusion purposes in trauima and post-operative situations
CHEST DRAINAGE
1. To evacuate air and/or fluid from the chest cavity or mediastinum
2. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum.
3. To help re-establish and maintain normal intra-thoracic pressure gradients.
4. To facilitate complete lung re-expansion to restore normal breathing dynamics.
The Pleur-evac® Autotransfusion Bag is indicated as a sterile, single use device used for collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac ®R System. The fluid path is non-pyrogemc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120953: Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120953
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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