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 Jun 9, 2017 as substantially equivalent to K093863 (Exmoor Plastics, Ltd., 2010) after a 333-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jun 9, 2017
- Review
- 333 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001731 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001731 Avid-Nit Loss of Resistance SyringeAvid Medical, Inc. · 2000 · Recalled
- 1 generation backK093863 EpidrumExmoor Plastics, Ltd. · 2010
- This deviceK161883 CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK221702 CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K221702CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001731 | Avid-Nit Loss of Resistance Syringe | Avid Medical, Inc. | 2000 | 1 |
| −1 | K093863 | Epidrum | Exmoor Plastics, Ltd. | 2010 | — |
| 0 (this device) | K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2017 | — |
| +1 | K221702 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 16.1 · 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 |
|---|---|---|---|
| * | K093863 | EpidrumSummary page 4…ic.com Common or Usual Name: Piston Syringe (21 CFR 880.5860, Product code: FMF) Predicate Devices Primary predicate device: Exmoor Plastics Limited, Epidrum (K093863) Reference device: Milestone Scientific, Inc. CompuFlo Infusion Pump (K053554) Intended Use / Indications for Use… | 2010 |
| † | K053554 | Compuflo | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221702 | CompuFlo Epidural Computer Controlled Anesthesia System | 2023 | 0 |
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 17 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K221702 (Milestone Scientific, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K093863.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161883 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161883: CompuFlo Epidural Computer Controlled Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161883
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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