# K221702: CompuFlo Epidural Computer Controlled Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Milestone Scientific, Inc.
- Decided: Feb 25, 2023 after 257 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: 3 generations back to K001731 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161883: CompuFlo Epidural Computer Controlled Anesthesia System, Milestone Scientific, Inc. (2017) Summary page 4.

## Indications for use
The CompuFlo® Epidural Computer Control Anesthesia System is intended for use with an epidural needle for the real-time verification of needle placement in the lumbar or thoracic epidural space, inclusive of cervicothoracic junction (CTJ). It is intended for patients over age of 18 who are required to have epidural needle or catheter placement as part of a medically necessary, in-patient or out-patient procedure, as established by their Health Care Provider (HCP). The CathCheck is an additional feature for clinicians to use to assess proper catheter placement inside the epidural space by evaluating a pulsatile waveform. The CathCheck function utilizes the same technology as the CompuFlo® Epidural Computer Control Anesthesia System and should only be used in conjunction with standard clinical assessment practice. Once the Health Care Provider verifies the epidural needle or catheter placement in the epidural space, the HCP continues with the medical procedure.

Source page: https://510kreport.com/device/K221702
Methodology: https://510kreport.com/methodology