# K962856: Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model S-100 Autotr

- Pathway: 510(k) (Traditional)
- Applicant: Deknatel, Inc.
- Decided: Aug 28, 1996 after 37 days
- Product code: KDQ (Bottle, Collection, Vacuum)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K801043 (1980). 6 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801043: E-Vax Chest Drainage System, Cardio Surgical Concepts, Inc. (1980) Summary page 1.
- K830671: Thorax-Klex Chest Drainage Unit, C.R. Bard, Inc. (1983) Summary page 1.
- K881252: Pleur-Evac (R) A6000 Adult/Pediatric Chest Drainage, Deknatel, Inc. (1988) Summary page 1.
- K905768: Pleur-Evac Chest Drainage Systems, Deknatel, Inc. (1991) Summary page 1.
- K854301: Pleur-Evac II Autotransfusion System, Deknatel, Inc. (1985) Summary page 1.
- K884844: Pleur-Evac (R) a-7002--Adult/Pediatric Drainage, Deknatel, Inc. (1989) Summary page 1.

## Most influential descendants
- K120953: Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System (2012), 3 descendants of its own
- K130043: Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System (2013), 2 descendants of its own
- K140205: Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System (2014), 1 descendant of its own
- K193361: ProCell Surgical Sponge-Blood Recovery Unit (2020), 0 descendants of its own
- K062302: Millicore AB Digivent Chest Drainage System (2006), 0 descendants of its own

## Recalls of this device
- Mar 13, 2015 · Class II · Z-1404-2015: Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

## Indications for use
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.

Source page: https://510kreport.com/device/K962856
Methodology: https://510kreport.com/methodology