# K060933: Solace Post-Operative Pain Relief Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Technologies, Inc.
- Decided: May 9, 2006 after 34 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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: 5 generations back to K813186 (1981). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051253: Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM), Baxter Healthcare Corp (2005)
- K040337: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump), I-Flow Corp. (2004) Summary page 1.
- K002380: Infusor SV, Infusor LV, Baxter Pain Management System, Baxter Healthcare Corp (2000) Summary page 1.
- K982946: Painbuster Infusion Kit, I-Flow Corp. (1998) Summary page 1.
- K984502: Nerve Block Infusion Kit, I-Flow Corp. (1999) Summary page 1.
- K043456: Modification to Soaker Catheter, I-Flow Corp. (2005) Summary page 1.

## Indications for use
The Solace Infusion System is intended for continuous infusion of medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.

Source page: https://510kreport.com/device/K060933
Methodology: https://510kreport.com/methodology