510(k) · Cleared
Recalled · Class I · 2021Portex Hypodermic Needle-Pro Fixed Needle Syringe
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 Feb 27, 2007 as substantially equivalent to K024249 (Terumo Medical Corp., 2003) after a 70-day review. Its family tree reaches back 4 generations to 1990. 1 of the 10 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 6 times, including a Class I recall.
- Decided
- Feb 27, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- MEG
- Recalls
- 6 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904198 (1990). 7 ancestors in all, the oldest K822083 (1982). 2 later devices descend from it, 2 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 3 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 2 generations backK011925 Hypodermic Needle-Pro Needle with Needle Protection Device…Sims Portex, Inc. · 2001 · Recalled
- 1 generation backK024249 Terumo Surguard Safety SyringeTerumo Medical Corp. · 2003
- This deviceK063755 Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK093176 Med-LokSta-Med, LLC · 2010
- Descendant · cites it directly · 0 of its ownK072482 Hypodermic Needle-Pro Safety Allergy TraySmiths Medical Asd, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −3 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −2 | K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic… | Sims Portex, Inc. | 2001 | 1 |
| −1 | K024249 | Terumo Surguard Safety Syringe | Terumo Medical Corp. | 2003 | — |
| 0 (this device) | K063755 | Portex Hypodermic Needle-Pro Fixed Needle Syringe | Smiths Medical Asd, Inc. | 2007 | — |
| +1 | K093176 | Med-Lok | Sta-Med, LLC | 2010 | — |
| +1 | K072482 | Hypodermic Needle-Pro Safety Allergy Tray | Smiths Medical Asd, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K024249 | Terumo Surguard Safety SyringeSummary page 1…podermic Syringe with attached needle protection Classification Name: 880.5860 Piston Syringe with Single Lumen Needle with antistick Predicate Device(s): K024249 (Terumo Medical Corporation) Terumo SurGuard TM Insulin, Allergy and General Use Safety Syringe and alternate brand name Port… | 2003 |
| † | K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro… | 2001 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| May 17, 2021 | Class I | Z-1798-2021 | Process control | Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward. |
| Jul 10, 2013 | Class II | Z-0642-2014 | Storage | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
| Jul 10, 2013 | Class II | Z-0644-2014 | Storage | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
| Jul 10, 2013 | Class II | Z-0645-2014 | Storage | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
| Jul 10, 2013 | Class II | Z-0643-2014 | Storage | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
| Jul 10, 2013 | Class II | Z-0646-2014 | Storage | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
The 5 latest of 6 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 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K093176 (Sta-Med, LLC, 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K024249.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 aspiration and injection of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
This device is intended for aspiration and injection of U-100 Insulin Only. 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/K063755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063755: Portex Hypodermic Needle-Pro Fixed Needle Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063755
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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