510(k) · Cleared
ClearedPortex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · MEG Syringe, Antistick
Cleared on Aug 24, 2006 as substantially equivalent to K041399 (Smiths Medical Asd, Inc., 2004) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 1990. 9 later devices descend from it.
- Decided
- Aug 24, 2006
- Review
- 118 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904198 (1990). 6 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 2 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 1 generation backK041399 Hypodermic Needle-Pro Edge Needle Protection DeviceSmiths Medical Asd, Inc. · 2004 · Recalled
- This deviceK061194 Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210…Smiths Medical Asd, Inc. · 2006
- 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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 | K041399 | Hypodermic Needle-Pro Edge Needle Protection Device | Smiths Medical Asd, Inc. | 2004 | 4 |
| 0 (this device) | K061194 | Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510… | Smiths Medical Asd, Inc. | 2006 | — |
| +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 |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 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 MEG? 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 MEG device
- #1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 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…d needle and needle protection. Classification Name: Syringe, Piston (21 CFR 880.5860, Product Code iW) Predicate Device(s): K041399 (Smiths Medical ASD, Inc.) Hypodermic Needle-Pro ® EDGE m Needle Protection… | 2004 |
| * | K030683 | Nipro Disposable SyringesSummary page 1…Needle-Pro ® EDGE m Needle Protection T Device K030683 (Nipro Corporation) Nipro®Disposable Syringes Device Description: This device consists of the two pr… | 2003 |
What descends from it? (9)
2 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)
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 16 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 6 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 MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, 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 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This device is intended for use to inject fluids into or withdraw fluids from the body. 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/K061194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061194: Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061194
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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