510(k) · Cleared
Recalled · Class II · 2018Avid-Nit Loss of Resistance Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avid Medical, Inc. · FMF Syringe, Piston
Cleared on Aug 29, 2000 after an 83-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it. It has been recalled once.
- Decided
- Aug 29, 2000
- Review
- 83 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK001731 Avid-Nit Loss of Resistance SyringeAvid Medical, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK093863 EpidrumExmoor Plastics, Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK081524 Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S…Spectra Medical Devices, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK161883 CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK221974 EpiFinderOmeq Medical, Ltd. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K093863EpidrumExmoor Plastics, Ltd. · 2010 · cites it directly3descendants
- K081524Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML Plastic…Spectra Medical Devices, Inc. · 2008 · cites it directly2descendants
- K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd. · 2017 · 2 generations on1descendant
- K161883CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2017 · 2 generations on1descendant
- K221974EpiFinderOmeq Medical, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001731 | Avid-Nit Loss of Resistance Syringe | Avid Medical, Inc. | 2000 | — |
| +1 | K093863 | Epidrum | Exmoor Plastics, Ltd. | 2010 | — |
| +1 | K081524 | Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML… | Spectra Medical Devices, Inc. | 2008 | — |
| +2 | K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +… | Intervene Group, Ltd. | 2017 | — |
| +2 | K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2017 | — |
| +2 | K221974 | EpiFinder | Omeq Medical, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2018 | Class II | Z-2016-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093863 (Exmoor Plastics, Ltd., 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K001731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001731: Avid-Nit Loss of Resistance Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001731
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026