# K960492: SI Controller Model SI 500

- Pathway: 510(k) (Traditional)
- Applicant: I.C Medical, Inc.
- Decided: Dec 23, 1996 after 325 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- 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 K932230 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932230: Crystal Vision and Accessories, I.C Medical, Inc. (1994) Summary page 1.
- K955166: Penevac SI., I.C Medical, Inc. (1996). Cleared while this submission was under review Summary page 1.
- (no number) Cabot Medical, Cabot Irrigation Pump: named in the summary without a submission number
- (no number) Nezhat-Dorsey Hydro-Dissection System: named in the summary without a submission number
- (no number) Bard/DavelEndo-FleJrrigation-§: named in the summary without a submission number

## Indications for use
The I.C. Medical SI Controller Model SI 500 is intended to be used to control the flow of irrigation fluids and vacuum to suction/irrigation and multifunction accessories having compatible suction/irrigation features during wound-eare-and-_open and closed surgical procedures. When used with appropriate accessories the SI Controller may be used for hydro-dissection. The SI Controller is not intended for use in delivering any blood or blood products

Source page: https://510kreport.com/device/K960492
Methodology: https://510kreport.com/methodology