510(k) · Cleared
ClearedPleur-Evac Shara Plus Model S-2150/Continuous Reinfusion Autotransfusion System (S-100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deknatel, Inc. · CAC Apparatus, Autotransfusion
Cleared on Nov 8, 1996 as substantially equivalent to K801043 (Cardio Surgical Concepts, Inc., 1980) and 6 other predicates after a 91-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Nov 8, 1996
- Review
- 91 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 1 generation to K801043 (1980). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK801043 E-Vax Chest Drainage SystemCardio Surgical Concepts, Inc. · 1980
- This deviceK963098 Pleur-Evac Shara Plus Model S-2150/Continuous Reinfusion…Deknatel, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801043 | E-Vax Chest Drainage System | Cardio Surgical Concepts, Inc. | 1980 | — |
| 0 (this device) | K963098 | Pleur-Evac Shara Plus Model S-2150/Continuous Reinfusion Autotransfusion… | Deknatel, Inc. | 1996 | — |
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 |
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? (7)
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 |
|---|---|---|---|
| * | K801043 | E-Vax Chest Drainage SystemSummary page 1…em is substantially equivalent in form, fit, function and intended use to the Thora-Klex Mode! 0077000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K801043A and #K830671, the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K881252 and #K90576… | 1980 |
| * | K830671 | Thorax-Klex Chest Drainage UnitSummary page 1…ially equivalent in form, fit, function and intended use to the Thora-Klex Mode! 0077000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K801043A and #K830671, the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K881252 and #K905768A, and the Pl… | 1983 |
| * | K881252 | Pleur-Evac (R) A6000 Adult/Pediatric Chest DrainageSummary page 1…System, cleared for marketing by FDA under 510(k)s #K801043A and #K830671, the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K881252 and #K905768A, and the Pleur- evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System, cleared for marketing by FDA u… | 1988 |
| * | K905768 | Pleur-Evac Chest Drainage SystemsSummary page 1…ed for marketing by FDA under 510(k)s #K801043A and #K830671, the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K881252 and #K905768A, and the Pleur- evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System, cleared for marketing by FDA under 510(k) #… | 1991 |
| * | K911656 | Pleur-Evac Plus Contin. Reinfus. & Autoinfus. SystSummary page 1…FDA under 510(k)s #K881252 and #K905768A, and the Pleur- evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System, cleared for marketing by FDA under 510(k) #K911656A. The Model S-100 Autotransfusion Bag, in specific, is substantially equivalent in form, fit, and function to the currently mark… | 1991 |
| * | K854301 | Pleur-Evac II Autotransfusion SystemSummary page 1…e currently marketed Pleur-evac Model A-1500 Autotransfusion Bag used with the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K 854301, #K881252, #K884844A, and used with the Pleur- evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System, cleared for… | 1985 |
| * | K884844 | Pleur-Evac (R) a-7002--Adult/Pediatric DrainageSummary page 1…Pleur-evac Model A-1500 Autotransfusion Bag used with the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K 854301, #K881252, #K884844A, and used with the Pleur- evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System, cleared for marketing by FDA und… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K801043.
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?
The Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System, is a sterile, non-pyrogenic, single use, three chamber collection/reinfusion device that is intended for collection and continuous reinfusion of autologous blood.
The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, used for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963098 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963098: Pleur-Evac Shara Plus Model S-2150/Continuous Reinfusion Autotransfusion System (S-100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963098
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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