# K992833: Vacuum Assist Stabilizer

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Thoracic Systems
- Decided: Nov 10, 1999 after 79 days
- Product code: MWS (Stabilizer, Heart)
- Device class: 1
- Regulation: 21 CFR 870.4500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964445 (1997). 1 ancestor in all.
159 later devices descend from it; 2 cite it directly.
1 of 161 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964445: Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006), Dlp, Inc. (1997) Summary page 1.

## Most influential descendants
- K041338: Medtronic Octopus TE Stabilizer & Accessories (2004), 157 descendants of its own
- K060391: Intuitive Surgical Endowrist Stabilizer, Model 420182 (2006), 155 descendants of its own
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 (2009), 153 descendants of its own
- K123463: Intuitive Surgical DA Vinci SI Surgical System Smartpedals (2012), 148 descendants of its own
- K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories (2014), 124 descendants of its own

## Indications for use
The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima™ OPCAB™ System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.

Source page: https://510kreport.com/device/K992833
Methodology: https://510kreport.com/methodology