510(k) · Cleared
Recalled · Class II · 2017Imc Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medsurg Connection · FMI Needle, Hypodermic, Single Lumen
Cleared on Jan 14, 2011 as substantially equivalent to K052474 (Nipro Medical Corp., 2005) after a 128-day review. Its family tree reaches back 2 generations to 1994. 12 later devices descend from it. It has been recalled 20 times.
- Decided
- Jan 14, 2011
- Review
- 128 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 20
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944355 (1994). 12 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 1 generation backK052474 Nipro Hypodermic NeedleNipro Medical Corp. · 2005
- This deviceK102584 Imc Hypodermic NeedleInternational Medsurg Connection · 2011
- Descendant · cites it directly · 8 of its ownK172483 Kopac Sterile NeedlePoonglim Pharmatech, Inc. · 2018
- Descendant · 2 generations on · 7 of its ownK192222 EZ-Inject Single use NeedlePoonglim Pharmatech, Inc. · 2020
- Descendant · 3 generations on · 6 of its ownK210444 EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK221860 PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV…Poonglim Pharmatech, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK250284 TSK SELECT™ NeedleTsk Laboratory, Japan · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K172483Kopac Sterile NeedlePoonglim Pharmatech, Inc. · 2018 · cites it directly8descendants
- K192222EZ-Inject Single use NeedlePoonglim Pharmatech, Inc. · 2020 · 2 generations on7descendants
- K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. · 2021 · 3 generations on6descendants
- K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc. · 2023 · 4 generations on1descendant
- K250284TSK SELECT™ NeedleTsk Laboratory, Japan · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −1 | K052474 | Nipro Hypodermic Needle | Nipro Medical Corp. | 2005 | — |
| 0 (this device) | K102584 | Imc Hypodermic Needle | International Medsurg Connection | 2011 | — |
| +1 | K172483 | Kopac Sterile Needle | Poonglim Pharmatech, Inc. | 2018 | — |
| +2 | K192222 | EZ-Inject Single use Needle | Poonglim Pharmatech, Inc. | 2020 | — |
| +3 | K210444 | EZ-Injec LDV Sterile Safety Needle | Poonglim Pharmatech, Inc. | 2021 | — |
| +4 | K221860 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead… | Poonglim Pharmatech, Inc. | 2023 | — |
| +4 | K250284 | TSK SELECT™ Needle | Tsk Laboratory, Japan | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K052474 | Nipro Hypodermic NeedleSummary page 1…e-mail: peterkimotintmedsurg.com Date Prepared: January 4, 2010 Predicate Devices: * Nipro Medical Corporation (K052474) Device Name(s): IMC Hypodermic Needle (non-sterile and sterile) Classification Panel: General Hospital Legally Marketed… | 2005 |
What descends from it? (12)
See all 124 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 |
|---|---|---|---|---|
| Jun 23, 2017 | Class II | Z-2822-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2811-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2809-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2813-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2805-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2812-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2814-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2815-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2807-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2818-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2806-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2816-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2810-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2817-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2820-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2821-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2819-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2823-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2824-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
| Jun 23, 2017 | Class II | Z-2808-2017 | Under Investigation by firm | Insufficient documentation to support product sterility claims. |
The 5 latest of 20 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K172483 (Poonglim Pharmatech, Inc., 2018) has gone furthest, with 8 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. 2011, 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?
This device 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 510(k) statement.
https://510kreport.com/device/K102584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102584: Imc 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/K102584
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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