510(k) · Cleared

Cleared

Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System

K963850510(k) TraditionalCleared Apr 22, 1997209-day reviewClass II21 CFR 868.5830

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Deknatel, Inc. · CAC Apparatus, Autotransfusion

Cleared on Apr 22, 1997 as substantially equivalent to K801043 (Cardio Surgical Concepts, Inc., 1980) and 6 other predicates after a 209-day review. Its family tree reaches back 1 generation to 1980. 5 later devices descend from it.

Decided: Apr 22, 1997
Review: 209 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. 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK801043 E-Vax Chest Drainage SystemCardio Surgical Concepts, Inc. · 1980
This deviceK963850 Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion…Deknatel, Inc. · 1997
Descendant · cites it directly · 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
Descendant · 4 generations on · 1 of its ownK140205 Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion…Teleflexmedical, Inc. · 2014 · Recalled
Descendant · 5 generations on · 0 of its ownK193361 ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc. · 2020

Most influential descendants

Showing 5 of 5 · See all

K031554S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemGenzyme Biosurgery · 2003 · cites it directly4descendants
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
K140205Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion SystemTeleflexmedical, Inc. · 2014 · 4 generations on1descendant
K193361ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc. · 2020 · 5 generations on0descendants

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)	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	—
+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	—
+4	K140205	Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System	Teleflexmedical, Inc.	2014	1
+5	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
2003	1	0
2012	1	0
2013	1	0
2014	1	0
2020	1	0

FIG. 1 — Lineage of K963850, 1980–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K801043	E-Vax Chest Drainage System Summary page 1 …em is substantially equivalent in form, fit, function and intended use to the Thora-Klex Model 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…	Cardio Surgical Concepts, Inc.	1980	—
*	K830671	Thorax-Klex Chest Drainage Unit Summary page 1 …ially equivalent in form, fit, function and intended use to the Thora-Klex Model 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…	C.R. Bard, Inc.	1983	—
*	K881252	Pleur-Evac (R) A6000 Adult/Pediatric Chest Drainage Summary 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…	Deknatel, Inc.	1988	—
*	K905768	Pleur-Evac Chest Drainage Systems Summary 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) #…	Deknatel, Inc.	1991	—
*	K911656	Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst Summary 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…	Pfizer Hospital Products Group, Inc.	1991	—
*	K854301	Pleur-Evac II Autotransfusion System Summary page 1 …e currently marketed Pleur-evac Model A-1500 Autotransfusion Bag used with the Pleur-evac Mode! A-8000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K 854301, #K881252, #K884844A, and used with the Pleur- evac Plus Mode! A-9150 Continuous Reinfusion Autotransfusion System, cleared for m…	Deknatel, Inc.	1985	—
*	K884844	Pleur-Evac (R) a-7002--Adult/Pediatric Drainage Summary page 1 …Pleur-evac Model A-1500 Autotransfusion Bag used with the Pleur-evac Mode! A-8000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K 854301, #K881252, #K884844A, and used with the Pleur- evac Plus Mode! A-9150 Continuous Reinfusion Autotransfusion System, cleared for marketing by FDA unde…	Deknatel, Inc.	1989	—

Also cleared against K801043: 2 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031554	S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System	Genzyme Biosurgery	2003	4

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.
Of its descendants, K031554 (Genzyme Biosurgery, 2003) has gone furthest, with 4 descendants of its own.
2 other devices also cite its predicate K801043.

How does its category compare?

All CAC devices

CAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAC

3in 2024

2007high 4 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAC

91in 2024

2007high 269 (2014) · low 90 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAC

7in 2023

2007high 25 (2009) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CAC

128in 2025

2007high 939 (2011) · low 12 (2008)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-1150 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/K963850 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963850: Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963850

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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