510(k) Report

510(k) · Cleared

Cleared

Nipro Hypodermic Needle

K052474510(k) TraditionalCleared Nov 10, 200562-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

Nipro Medical Corp. · FMI Needle, Hypodermic, Single Lumen

Cleared on Nov 10, 2005 as substantially equivalent to K944355 (Nissho Corp., 1994) after a 62-day review. Its family tree reaches back 1 generation to 1994. 13 later devices descend from it.

Decided
Nov 10, 2005
Review
62 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K944355 (1994). 13 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2024: 3 descendants cleared2023: 3 descendants cleared2018: 2 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant clearedK944355 · Nipro Branded Disposable Syringes, Needles · Nissho Corp. · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 5 descendants6 generations forward: 1 descendant K944355 · Nipro Branded Disposable Syringes, Needles · Nissho Corp. · 19940+5
  1. Root · 1 generation backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
  2. This deviceK052474 Nipro Hypodermic NeedleNipro Medical Corp. · 2005
  3. Descendant · cites it directly · 12 of its ownK102584 Imc Hypodermic NeedleInternational Medsurg Connection · 2011 · Recalled
  4. Descendant · 2 generations on · 8 of its ownK172483 Kopac Sterile NeedlePoonglim Pharmatech, Inc. · 2018
  5. Descendant · 3 generations on · 7 of its ownK192222 EZ-Inject Single use NeedlePoonglim Pharmatech, Inc. · 2020
  6. Descendant · 4 generations on · 6 of its ownK210444 EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. · 2021
  7. Descendant · 5 generations on · 1 of its ownK221860 PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV…Poonglim Pharmatech, Inc. · 2023

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2011: 12018: 22020: 12021: 12022: 12023: 32024: 32025: 1
2011high 3 (2023) · low 0 (2012)2026

Most influential descendants

Showing 5 of 13 · See all
  • K102584Imc Hypodermic NeedleInternational Medsurg Connection · 2011 · cites it directly12descendants
  • K172483Kopac Sterile NeedlePoonglim Pharmatech, Inc. · 2018 · 2 generations on8descendants
  • K192222EZ-Inject Single use NeedlePoonglim Pharmatech, Inc. · 2020 · 3 generations on7descendants
  • K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. · 2021 · 4 generations on6descendants
  • K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc. · 2023 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944355Nipro Branded Disposable Syringes, NeedlesNissho Corp.1994—
0 (this device)K052474Nipro Hypodermic NeedleNipro Medical Corp.2005—
+1K102584Imc Hypodermic NeedleInternational Medsurg Connection201120
+2K172483Kopac Sterile NeedlePoonglim Pharmatech, Inc.2018—
+3K192222EZ-Inject Single use NeedlePoonglim Pharmatech, Inc.2020—
+4K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc.2021—
+5K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead…Poonglim Pharmatech, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201820
202010
202110
202210
202330
202430
202510
FIG. 1 — Lineage of K052474, 1994–2025Source: 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
*K944355Nipro Branded Disposable Syringes, Needles
Summary page 1
…80 807.92 (a)(3) Legally Marketed Substantially Equivalent Device: Nipro Branded Disposable Syringes and Needles (K944355) 807.92 (a)(4) Description of Device: The subject devices can be classified as single u…
Nissho Corp.1994—

Also cleared against K944355: 5 other devices →

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102584Imc Hypodermic NeedleInternational Medsurg Connection201112

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?

  • Its one ancestor has no recall.
  • Of its descendants, K102584 (International Medsurg Connection, 2011) has gone furthest, with 12 descendants of its own.
  • 5 other devices also cite its predicate K944355.

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.

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 Nipro Hypodermic Needle is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

Indications for use as stated in the FDA summary.

Also cleared against K944355

5 other devices cite the same predicate.

  • K130049Monoject 12ML SyringeNipro Medical Corporation · 2013
  • K091279Nipro Disposable SyringeNipro Medical Corporation · 2009
  • K051574Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005
  • K030683Nipro Disposable SyringesNipro Medical Corp. · 2003
  • K013293Nipro Hypodermic NeedleNipro Medical Corp. · 2001

More from Nipro Medical Corp.

27 FDA decisions under this applicant name. See the company

  • K093985Nipro Safetouch Locktail Safety Fistula NeedleNipro Medical Corp. · 2010
  • K081210Nipro Safetouch Huber Infustion SetNipro Medical Corp. · 20081 recall
  • K072024Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693Nipro Medical Corp. · 20071 recall
  • K063368Nipro Biohole NeedleNipro Medical Corp. · 2007
  • K063721Nipro Safetouch II GammaNipro Medical Corp. · 2007

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/K052474 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052474: Nipro Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052474

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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