510(k) Report

510(k) · Cleared

Cleared

MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®

K230070510(k) AbbreviatedCleared Oct 5, 2023268-day reviewClass II21 CFR 880.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Promamedical, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Oct 5, 2023 as substantially equivalent to K161255 (Biotekne Srl, 2017) after a 268-day review. Its family tree reaches back 3 generations to 2005.

Decided
Oct 5, 2023
Review
268 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K051783 (2005). No later device cites it as a predicate yet.

K051783 · Artsana Pen Needles, Artsana Injection Needles · Artsana S.P.A · 2005K110606 · MV Intradermic Needles; Magic Needle; Magic Needle · M.V.S.R.L. · 2011K161255 · meso-relle (AAL34, AAL36, AM30G) · Biotekne Srl · 201720052010201520202025
K161255 · meso-relle (AAL34, AAL36, AM30G) · Biotekne Srl · 2017K110606 · MV Intradermic Needles; Magic Needle; Magic Needle · M.V.S.R.L. · 2011K051783 · Artsana Pen Needles, Artsana Injection Needles · Artsana S.P.A · 20050
  1. Root · 3 generations backK051783 Artsana Pen Needles, Artsana Injection NeedlesArtsana S.P.A · 2005
  2. 2 generations backK110606 MV Intradermic Needles; Magic Needle; Magic NeedleM.V.S.R.L. · 2011
  3. 1 generation backK161255 meso-relle (AAL34, AAL36, AM30G)Biotekne Srl · 2017
  4. This deviceK230070 MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle…Promamedical, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K051783Artsana Pen Needles, Artsana Injection NeedlesArtsana S.P.A2005—
−2K110606MV Intradermic Needles; Magic Needle; Magic NeedleM.V.S.R.L.2011—
−1K161255meso-relle (AAL34, AAL36, AM30G)Biotekne Srl2017—
0 (this device)K230070MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302)…Promamedical, Inc.2023—
FIG. 1 — Lineage of K230070, 2005–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K161255meso-relle (AAL34, AAL36, AM30G)
Summary page 5
…Classification Panel: General Hospital 3. Predicate Device Information Trade Name: Meso-Relle (AAL34, AAL36, AM30G) 510(k) Number: K161255 Common Name: Hypodermic Needle Device Classification: Name: Needle, Hypodermic, Single Lumen…
Biotekne Srl2017—

What descends from it?

No later submission names this one as a predicate yet.

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 18 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
  • None of the 3 ancestors has a recall.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · FMI

11in 2025

2007: 152008: 102009: 72010: 152011: 122012: 172013: 112014: 142015: 102016: 202017: 92018: 202019: 122020: 112021: 182022: 232023: 182024: 32025: 112026 (partial year): 12
2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007: 71 days median2008: 85 days median2009: 177 days median2010: 119 days median2011: 113 days median2012: 107 days median2013: 87 days median2014: 155 days median2015: 89 days median2016: 217 days median2017: 253 days median2018: 176 days median2019: 186 days median2020: 263 days median2021: 143 days median2022: 189 days median2023: 112 days median2024: 90 days median2025: 141 days median2026 (partial year): 119 days median
2007high 263 (2020) · low 71 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMI

1in 2024

2007: 22008: 42009: 32010: 792011: 52012: 12013: 12014: 32015: 12017: 162019: 52020: 32021: 72023: 22024: 12026 (partial year): 1, 1 Class I
2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007: 2082008: 1772009: 2632010: 2492011: 2402012: 2152013: 2552014: 2872015: 5672016: 9412017: 1,5472018: 2,3982019: 4,8962020: 4,2452021: 4,5322022: 4,8852023: 4,9862024: 4,0532025: 2,424
2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715712208
200810854177
200971773263
20101511979249
2011121135240
2012171071215
201311871255
2014141553287
201510891567
2016202170941
20179253161,547
20182017602,398
20191218654,896
20201126334,245
20211814374,532
20222318904,885
20231811224,986
202439014,053
20251114102,424
2026121191 (1)—

What is it indicated for?

The MESORAM® Hypodermic Needles are intended to inject fluids intradermally.

Indications for use as stated in the FDA summary.

Recent decisions in FMI

The FMI category page

  • K261266MOWANA™ Auto DuoPentamaster Mediq SDN BHD · 2026
  • K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2026
  • K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety…Hh Global Technology, Inc. · 2026
  • K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R…Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026
  • K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd. · 2026

https://510kreport.com/device/K230070 · printed Nov 6, 2026

Cite this page

510(k) Report. “K230070: MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230070

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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