510(k) · Cleared
ClearedKopac Sterile Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Poonglim Pharmatech, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jun 21, 2018 as substantially equivalent to K102584 (International Medsurg Connection, 2011) after a 309-day review. Its family tree reaches back 3 generations to 1994. 8 later devices descend from it.
- Decided
- Jun 21, 2018
- Review
- 309 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944355 (1994). 8 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 2 generations backK052474 Nipro Hypodermic NeedleNipro Medical Corp. · 2005
- 1 generation backK102584 Imc Hypodermic NeedleInternational Medsurg Connection · 2011 · Recalled
- This deviceK172483 Kopac Sterile NeedlePoonglim Pharmatech, Inc. · 2018
- Descendant · cites it directly · 7 of its ownK192222 EZ-Inject Single use NeedlePoonglim Pharmatech, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK210444 EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK221860 PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV…Poonglim Pharmatech, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK250284 TSK SELECT™ NeedleTsk Laboratory, Japan · 2025
- Descendant · 4 generations on · 0 of its ownK241190 PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV…Poonglim Pharmatech, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K192222EZ-Inject Single use NeedlePoonglim Pharmatech, Inc. · 2020 · cites it directly7descendants
- K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. · 2021 · 2 generations on6descendants
- K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc. · 2023 · 3 generations on1descendant
- K250284TSK SELECT™ NeedleTsk Laboratory, Japan · 2025 · 3 generations on0descendants
- K241190PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −2 | K052474 | Nipro Hypodermic Needle | Nipro Medical Corp. | 2005 | — |
| −1 | K102584 | Imc Hypodermic Needle | International Medsurg Connection | 2011 | 20 |
| 0 (this device) | K172483 | Kopac Sterile Needle | Poonglim Pharmatech, Inc. | 2018 | — |
| +1 | K192222 | EZ-Inject Single use Needle | Poonglim Pharmatech, Inc. | 2020 | — |
| +2 | K210444 | EZ-Injec LDV Sterile Safety Needle | Poonglim Pharmatech, Inc. | 2021 | — |
| +3 | K221860 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead… | Poonglim Pharmatech, Inc. | 2023 | — |
| +3 | K250284 | TSK SELECT™ Needle | Tsk Laboratory, Japan | 2025 | — |
| +4 | K241190 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead… | Poonglim Pharmatech, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K102584 | Imc Hypodermic NeedleSummary page 4…5) Regulation number : 880.5570 6) Class of device : Class II 7) Panel : General hospital 3. The legally marketed device to which we are claiming equivalence K102584, IMC hypodermic Needle 4. Device description The device consists of a metal tube that is beveled at one end and at the other… | 2011 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192222 | EZ-Inject Single use Needle | 2020 | 7 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K192222 (Poonglim Pharmatech, Inc., 2020) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K102584.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172483: Kopac Sterile Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172483
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