510(k) · Cleared
ClearedCompuFlo Epidural Computer Controlled Anesthesia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Milestone Scientific, Inc. · FMF Syringe, Piston
Cleared on Feb 25, 2023 as substantially equivalent to K161883 (Milestone Scientific, Inc., 2017) after a 257-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Feb 25, 2023
- Review
- 257 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001731 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001731 Avid-Nit Loss of Resistance SyringeAvid Medical, Inc. · 2000 · Recalled
- 2 generations backK093863 EpidrumExmoor Plastics, Ltd. · 2010
- 1 generation backK161883 CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2017
- This deviceK221702 CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001731 | Avid-Nit Loss of Resistance Syringe | Avid Medical, Inc. | 2000 | 1 |
| −2 | K093863 | Epidrum | Exmoor Plastics, Ltd. | 2010 | — |
| −1 | K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2017 | — |
| 0 (this device) | K221702 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161883 | CompuFlo Epidural Computer Controlled Anesthesia SystemSummary page 4…thesia System is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Predicate/Reference K161883 CompuFlo® Epidural Computer Controlled Pr… | 2017 |
| † | K201356 | Plastic LOR Syringe | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
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…
Read the full statement (145 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221702 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221702: CompuFlo Epidural Computer Controlled Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221702
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026