510(k) · Cleared
Clearedmeso-relle (AAL34, AAL36, AM30G)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotekne Srl · FMI Needle, Hypodermic, Single Lumen
Cleared on Jan 19, 2017 as substantially equivalent to K110606 (M.V.S.R.L., 2011) after a 261-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Jan 19, 2017
- Review
- 261 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051783 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK051783 Artsana Pen Needles, Artsana Injection NeedlesArtsana S.P.A · 2005
- 1 generation backK110606 MV Intradermic Needles; Magic Needle; Magic NeedleM.V.S.R.L. · 2011
- This deviceK161255 meso-relle (AAL34, AAL36, AM30G)Biotekne Srl · 2017
- Descendant · cites it directly · 0 of its ownK230070 MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle…Promamedical, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230070MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM®…Promamedical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051783 | Artsana Pen Needles, Artsana Injection Needles | Artsana S.P.A | 2005 | — |
| −1 | K110606 | MV Intradermic Needles; Magic Needle; Magic Needle | M.V.S.R.L. | 2011 | — |
| 0 (this device) | K161255 | meso-relle (AAL34, AAL36, AM30G) | Biotekne Srl | 2017 | — |
| +1 | K230070 | MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302)… | Promamedical, 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 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 |
|---|---|---|---|
| * | K110606 | MV Intradermic Needles; Magic Needle; Magic NeedleSummary page 4…assification name: Hypodermic single lumen needle, 21 CFR 880.5570, Class II D. Product Code: FMI LEGALLY MARKETED DEVICES (PREDICATE DEVICES) K110606, MV Intradermic Needles, MV S.R.L. Reference Predicate Device: K051783, Artsana Hypodermic Needles, ARTSANA SPA. Section 05 r… | 2011 |
| † | K051783 | Artsana Pen Needles, Artsana Injection Needles | 2005 |
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 |
|---|---|---|---|
| K230070 | MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM®… | 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 12 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230070 (Promamedical, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The meso-relle needles are intended to inject fluids intradermally.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161255: meso-relle (AAL34, AAL36, AM30G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161255
Report an extraction error
Are you the manufacturer?
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