510(k) · Cleared

Recalled · Class II · 2015

Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model S-100 Autotr

K962856510(k) TraditionalCleared Aug 28, 199637-day reviewClass II21 CFR 880.6740Recalls 1

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

Deknatel, Inc. · KDQ Bottle, Collection, Vacuum

Cleared on Aug 28, 1996 as substantially equivalent to K801043 (Cardio Surgical Concepts, Inc., 1980) and 5 other predicates after a 37-day review. Its family tree reaches back 1 generation to 1980. 5 later devices descend from it. It has been recalled once.

Decided: Aug 28, 1996
Review: 37 days
Class: Class II
Product code: KDQ
Recalls: 1
Predicates: 6

Its longest line of descent runs back 1 generation to K801043 (1980). 6 ancestors in all. 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK801043 E-Vax Chest Drainage SystemCardio Surgical Concepts, Inc. · 1980
This deviceK962856 Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model…Deknatel, Inc. · 1996
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
Descendant · cites it directly · 0 of its ownK062302 Millicore AB Digivent Chest Drainage SystemMillicore AB · 2006

Most influential descendants

Showing 5 of 5 · 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
K062302Millicore AB Digivent Chest Drainage SystemMillicore AB · 2006 · cites it directly0descendants

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)	K962856	Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200…	Deknatel, Inc.	1996	—
+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	—
+1	K062302	Millicore AB Digivent Chest Drainage System	Millicore AB	2006	—

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	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2012	1	0
2013	1	0
2014	1	0
2020	1	0

FIG. 1 — Lineage of K962856, 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 KDQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (6)

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 …g are 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, and the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K881252 and #K9…	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, and the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K881252 and #K905768A. The M…	C.R. Bard, Inc.	1983	—
*	K881252	Pleur-Evac (R) A6000 Adult/Pediatric Chest Drainage Summary page 1 …em, cleared for marketing by FDA under 510(k)s #K801043A and #K830671, and the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K881252 and #K905768A. The Model S-100 Autotransfusion Bag, in specific, is substantially equivalent in form, fit, and function, to the…	Deknatel, Inc.	1988	—
*	K905768	Pleur-Evac Chest Drainage Systems Summary page 1 …or marketing by FDA under 510(k)s #K801043A and #K830671, and the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K881252 and #K905768A. The Model S-100 Autotransfusion Bag, in specific, is substantially equivalent in form, fit, and function, to the currently mar…	Deknatel, 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 Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K 854301, #K881252 and #K884844A. Device Déscription: Pleur-evac Sahara Adult/Pediatric Chest Drainage System Models S-1100, S-1200, S-2…	Deknatel, Inc.	1985	—
*	K884844	Pleur-Evac (R) a-7002--Adult/Pediatric Drainage Summary page 1 …ur-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 and #K884844A. Device Déscription: Pleur-evac Sahara Adult/Pediatric Chest Drainage System Models S-1100, S-1200, S-2100, and S-2200 Deknat…	Deknatel, Inc.	1989	—

Also cleared against K801043: 2 other devices →

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120953	Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System	Tlelflex Medical, Inc.	2012	3
K062302	Millicore AB Digivent Chest Drainage System	Millicore AB	2006	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 13, 2015	Class II	Z-1404-2015	Other	Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 6 ancestors has a recall.
Of its descendants, K120953 (Tlelflex Medical, Inc., 2012) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K801043.

How does its category compare?

All KDQ devices

KDQ Bottle, Collection, Vacuum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDQ

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDQ

Too few KDQ 510(k)s in any year since 2007 to give a median.

Recalls per year · KDQ

1in 2023

2007high 2 (2009) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KDQ

49in 2025

2007high 165 (2009) · low 22 (2012)2025

MAUDE reports naming product code KDQ, 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	—	0	48
2008	1	—	0	67
2009	0	—	2	165
2010	0	—	1	50
2011	0	—	0	40
2012	0	—	0	22
2013	0	—	0	44
2014	0	—	2	43
2015	0	—	1 (1)	34
2016	0	—	1	77
2017	0	—	0	53
2018	0	—	0	45
2019	0	—	1	57
2020	0	—	0	110
2021	0	—	1	110
2022	0	—	1	118
2023	0	—	1	92
2024	0	—	0	164
2025	0	—	0	49
2026	0	—	0	—

What is it indicated for?

The Models S-1100, S-1200, S-2100, and S-2200 covered by this submission are sterile, single use devices, that are intended for postoperative chest drainage.

The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, intended for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Chest Drainage.

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/K962856 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962856: Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model S-100 Autotr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962856

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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