510(k) · Cleared
Recalled · 2004Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle Protectio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Portex, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jul 12, 2001 as substantially equivalent to K923127 (Concord/Portex, 1993) after a 22-day review. Its family tree reaches back 2 generations to 1990. 1 of the 8 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 12, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904198 (1990). 5 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 1 generation backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- This deviceK011925 Hypodermic Needle-Pro Needle with Needle Protection Device…Sims Portex, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK024249 Terumo Surguard Safety SyringeTerumo Medical Corp. · 2003
- Descendant · 2 generations on · 2 of its ownK063755 Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK093176 Med-LokSta-Med, LLC · 2010
- Descendant · 2 generations on · 0 of its ownK072482 Hypodermic Needle-Pro Safety Allergy TraySmiths Medical Asd, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK014073 Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection…Portex, Inc. · 2002
Class I recalls in this family
- K063755 Portex Hypodermic Needle-Pro Fixed Needle Syringe2 generations on · 2007
Most influential descendants
Showing 5 of 5 · See all- K024249Terumo Surguard Safety SyringeTerumo Medical Corp. · 2003 · cites it directly3descendants
- K063755Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007 · 2 generations on2descendants
- K093176Med-LokSta-Med, LLC · 2010 · 3 generations on0descendants
- K072482Hypodermic Needle-Pro Safety Allergy TraySmiths Medical Asd, Inc. · 2007 · 2 generations on0descendants
- K014073Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection DevicePortex, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −1 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| 0 (this device) | K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic… | Sims Portex, Inc. | 2001 | — |
| +1 | K024249 | Terumo Surguard Safety Syringe | Terumo Medical Corp. | 2003 | — |
| +2 | K063755 | Portex Hypodermic Needle-Pro Fixed Needle Syringe | Smiths Medical Asd, Inc. | 2007 | Class I |
| +3 | K093176 | Med-Lok | Sta-Med, LLC | 2010 | — |
| +2 | K072482 | Hypodermic Needle-Pro Safety Allergy Tray | Smiths Medical Asd, Inc. | 2007 | — |
| +1 | K014073 | Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection Device | Portex, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 1 |
| 2010 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K923127 | Needle-Pro CartridgeSummary page 2…880.5570 (Hypodermic Single Lumen Needles) This filing is under FMI as the needle protection device is attached to the needle. 28 PREDICATE DEVICE(S): K923127 Needle-Pro™ Cartridge DESCRIPTION: This device is intended for injection or aspiration of fluids utilizing a luer slip syringe.… | 1993 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2004 | Not classified | Z-1078-04 | Other | Sterility of product is not assured |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K063755Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K024249 (Terumo Medical Corp., 2003) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K923127.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The Needle-Pro® device is not designed for use with a luer lock syringe.
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/K011925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011925: Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle Protectio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011925
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026