510(k) · Cleared
ClearedEpidrum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exmoor Plastics, Ltd. · FMF Syringe, Piston
Cleared on May 10, 2010 as substantially equivalent to K001731 (Avid Medical, Inc., 2000) after a 144-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- May 10, 2010
- Review
- 144 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001731 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001731 Avid-Nit Loss of Resistance SyringeAvid Medical, Inc. · 2000 · Recalled
- This deviceK093863 EpidrumExmoor Plastics, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK161883 CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK221974 EpiFinderOmeq Medical, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK221702 CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K161883CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2017 · cites it directly1descendant
- K221974EpiFinderOmeq Medical, Ltd. · 2023 · cites it directly0descendants
- K221702CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001731 | Avid-Nit Loss of Resistance Syringe | Avid Medical, Inc. | 2000 | 1 |
| 0 (this device) | K093863 | Epidrum | Exmoor Plastics, Ltd. | 2010 | — |
| +1 | K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2017 | — |
| +1 | K221974 | EpiFinder | Omeq Medical, Ltd. | 2023 | — |
| +2 | K221702 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 2 | 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 16.2 · 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 |
|---|---|---|---|
| * | K001731 | Avid-Nit Loss of Resistance SyringeSummary page 2…Page 2 Equivalent Device: Avid-Nit Loss of Resistance Syringe 510K Number: K001731 Manufacturer: Avid Medical Inc. 9000 Westmont Drive… | 2000 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Epidrum is intended far use, in conjunction with an epidural needle, to
verify the needle tip placement in the epidural space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093863 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093863: Epidrum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093863
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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