# K161883: CompuFlo Epidural Computer Controlled Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Milestone Scientific, Inc.
- Decided: Jun 9, 2017 after 333 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001731 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093863: Epidrum, Exmoor Plastics, Ltd. (2010) Summary page 4.

## Most influential descendants
- K221702: CompuFlo Epidural Computer Controlled Anesthesia System (2023), 0 descendants of its own

## Indications for use
The CompuFlo Epidural Computer Controlled Anesthesia System is intended for use with an epidural needle for the real time verification of needle tip placement in the lumbar epidural space in patients over the age of 18 who are required to have epidural needle placement as part of a medically necessary, in-patient or out-patient procedure, as established by their Health Care Provider. Once Health Care Provider verifies the epidural needle placement in the lumbar epidural space, Compuflo Epidural Computer Controlled Anesthesia System is disconnected and HCP continues with the medical procedure.

Source page: https://510kreport.com/device/K161883
Methodology: https://510kreport.com/methodology