510(k) · Cleared
ClearedTerumo Surguard Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · MEG Syringe, Antistick
Cleared on Feb 21, 2003 as substantially equivalent to K822083 (Terumo Medical Corp., 1982) and 2 other predicates after a 60-day review. Its family tree reaches back 3 generations to 1990. 1 of the 10 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Feb 21, 2003
- Review
- 60 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904198 (1990). 6 ancestors in all, the oldest K822083 (1982). 3 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 · 3 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 2 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 1 generation backK011925 Hypodermic Needle-Pro Needle with Needle Protection Device…Sims Portex, Inc. · 2001 · Recalled
- This deviceK024249 Terumo Surguard Safety SyringeTerumo Medical Corp. · 2003
- Descendant · cites it directly · 2 of its ownK063755 Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 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
Class I recalls in this family
- K063755 Portex Hypodermic Needle-Pro Fixed Needle Syringecites it directly · 2007
Most influential descendants
Showing 3 of 3 · See allView 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 | K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic… | Sims Portex, Inc. | 2001 | 1 |
| 0 (this device) | 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 |
| +2 | 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 | 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 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? (3)
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 |
|---|---|---|---|
| * | K822083 | U-100 Insulin SyringeSummary page 2…is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Insulin Syringe (K822083), the Teruino Allergy Syringe (K980796), and the Portex Needle-Pro@ Syringe (KO 1 1925). Terumo Medical C… | 1982 |
| * | K980796 | Terumo Allergy SyringeSummary page 2…top of the syringe barrel. The syringe portion is the same as Terumo’s Insulin and Terumo’s Allergy/General Syringe that are the subject of K882083 and K980796 respectively. No changes were made to the syringes other than a minor modification to outside of the barrel to al… | 1998 |
| * | K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro… | 2001 |
What descends from it? (3)
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)
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 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K063755 (Smiths Medical Asd, Inc., 2007) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K822083.
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?
The Surguard Safety Syringe is a device intended for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The syringe will also be used to withdraw medication from vials. This device is intended for insulin, allergy, or general use injections. Additionally, after withdrawing the needle from the patient, the safety feature can be manually activated to cover the needle to minimize the risk of accidental needlestick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024249 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024249: Terumo Surguard Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024249
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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