510(k) · Cleared
ClearedSpectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML Plastic Loss of Resistance Syringe L/L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectra Medical Devices, Inc. · FMF Syringe, Piston
Cleared on Jul 29, 2008 as substantially equivalent to K001731 (Avid Medical, Inc., 2000) after a 57-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Jul 29, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001731 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001731 Avid-Nit Loss of Resistance SyringeAvid Medical, Inc. · 2000 · Recalled
- This deviceK081524 Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S…Spectra Medical Devices, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK201031 NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView 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) | K081524 | Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML… | Spectra Medical Devices, Inc. | 2008 | — |
| +1 | K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +… | Intervene Group, Ltd. | 2017 | — |
| +2 | K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | International Medical Industries, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K001731 | Avid-Nit Loss of Resistance SyringeSummary page 1…d medical journal articles. The LOR Syringe is not intended for injection or aspiration. Predicate Device: AVID-NIT Loss of Resistance Syringe, FDA 510(K) # K001731 Device Description: The construction of the SPECTRA-LOR, Loss of Resistance Syringe is similar to that of a standard piston syr… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6… | 2017 | 1 |
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. 2008, 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 "SPECTRA - LOR", Loss of Resistance Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in. the epidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081524: Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML Plastic Loss of Resistance Syringe L/L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081524
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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