510(k) · Cleared
ClearedHypodermic Needle-Pro Safety Allergy Tray
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 Nov 29, 2007 as substantially equivalent to K063755 (Smiths Medical Asd, Inc., 2007) and 1 other predicate after an 86-day review. Its family tree reaches back 5 generations to 1990. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 29, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904198 (1990). 8 ancestors in all, the oldest K822083 (1982). No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 4 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 3 generations backK011925 Hypodermic Needle-Pro Needle with Needle Protection Device…Sims Portex, Inc. · 2001 · Recalled
- 2 generations backK024249 Terumo Surguard Safety SyringeTerumo Medical Corp. · 2003
- 1 generation backK063755 Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007 · Recalled (Class I)
- This deviceK072482 Hypodermic Needle-Pro Safety Allergy TraySmiths Medical Asd, Inc. · 2007
Class I recalls in this family
- K063755 Portex Hypodermic Needle-Pro Fixed Needle Syringedirect predicate · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −4 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −3 | K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic… | Sims Portex, Inc. | 2001 | 1 |
| −2 | K024249 | Terumo Surguard Safety Syringe | Terumo Medical Corp. | 2003 | — |
| −1 | K063755 | Portex Hypodermic Needle-Pro Fixed Needle Syringe | Smiths Medical Asd, Inc. | 2007 | Class I |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K063755 | Portex Hypodermic Needle-Pro Fixed Needle SyringeSummary page 1…rmic Syringe with attached needle protection Classification Name: 880.5860 Piston Syringe with Single Lumen Needle with antistick Predicate Device(s): K063 755 (Smiths Medical ASD, Inc) Portex® Hypodermic Needle-Pro® Fixed Needle TB Syringe K(024249 (Terumo Medical Corporation… | 2007 |
| * | K024249 | Terumo Surguard Safety SyringeSummary page 1…gle Lumen Needle with antistick Predicate Device(s): K063 755 (Smiths Medical ASD, Inc) Portex® Hypodermic Needle-Pro® Fixed Needle TB Syringe K(024249 (Terumo Medical Corporation) Terumno SurGuard T M Insulin, Allergy and General Use Safety Syringe and alternate brand name P… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · Direct predicate · ◆ on the line of descent in FIG. 11 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 2.4 years on median.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K063755.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072482 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072482: Hypodermic Needle-Pro Safety Allergy Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072482
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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