# K023083: Silberg T.P.S., Tissue Preparation System, Model ME 800

- Pathway: 510(k) (Abbreviated)
- Applicant: Mettler Electronics Corp.
- Decided: Feb 28, 2003 after 164 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K934846 (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)
- K934846: Sonicator 716, Mettler Electronics Corp. (1994) Summary page 1.
- K991203: Irrigation or Infusion Pump K Pump, Kmi Kolster Methods, Inc. (1999) Summary page 1.

## Indications for use
The one megahertr ultrasoundlperistaltic imgation pump combination system, bade name Silberg T.P.S. (Tissue Preparation System), provides a method for the subcutaneous infusion and ultrasonic dispersion of tumescent fluid. It is not indicated for the administration of parenteral fluids, infusion of drugs, or for any lifesustaining purpose.

Source page: https://510kreport.com/device/K023083
Methodology: https://510kreport.com/methodology