510(k) · Cleared
ClearedPortex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jan 25, 2007 as substantially equivalent to K041399 (Smiths Medical Asd, Inc., 2004) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1990. 8 later devices descend from it.
- Decided
- Jan 25, 2007
- Review
- 71 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904198 (1990). 8 ancestors in all, the oldest K771203 (1977). 8 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 2 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 1 generation backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- This deviceK063450 Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810…Smiths Medical Asd, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK071785 Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge…Smiths Medical Asd, Inc. · 2007
- Descendant · 2 generations on · 5 of its ownK211634 Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK232943 Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc. · 2024
- Descendant · 4 generations on · 2 of its ownK242291 SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip…Sol-Millennium Medical, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK253110 Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K071785Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with…Smiths Medical Asd, Inc. · 2007 · cites it directly7descendants
- K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc. · 2021 · 2 generations on5descendants
- K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc. · 2024 · 3 generations on4descendants
- K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…Sol-Millennium Medical, Inc. · 2024 · 4 generations on2descendants
- K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −2 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −1 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| 0 (this device) | K063450 | Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1… | Smiths Medical Asd, Inc. | 2007 | — |
| +1 | K071785 | Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety… | Smiths Medical Asd, Inc. | 2007 | — |
| +2 | K211634 | Hypodermic Needle-Pro EDGE Safety Device | Smiths Medical Asd, Inc. | 2021 | — |
| +3 | K232943 | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe | Smiths Medical Asd, Inc. | 2024 | — |
| +4 | K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe… | Sol-Millennium Medical, Inc. | 2024 | — |
| +5 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K041399 | Hypodermic Needle-Pro Edge Needle Protection DeviceSummary page 1…ic Needle with attached needle protection Classification Name: Hypodermic Single Lumen Needles (21 CFR 880.5570, Product Code FMI) Predicate Device(s): K041399 (Smiths Medical ASD, Inc.) Hypodermic Needle-Pro® EDGE TM Needle Protection Device K031453 (Terumo Medical Corporation… | 2004 |
| * | K031453 | Terumo Surguard 2 Safety NeedleSummary page 1…21 CFR 880.5570, Product Code FMI) Predicate Device(s): K041399 (Smiths Medical ASD, Inc.) Hypodermic Needle-Pro® EDGE TM Needle Protection Device K031453 (Terumo Medical Corporation) SurGuard2 T M Safety Hypodermic Needle Device Description: This device is intended for i… | 2003 |
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 |
|---|---|---|---|
| K071785 | Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with… | 2007 | 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 17 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K071785 (Smiths Medical Asd, Inc., 2007) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K041399.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063450: Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063450
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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