510(k) · Cleared
Recalled · 2010Secureguard Retractable Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safegard Medical Products, Inc. · MEG Syringe, Antistick
Cleared on Oct 24, 2001 after a 110-day review. The FDA summary names its predicate without a number. 22 later devices descend from it. It has been recalled once.
- Decided
- Oct 24, 2001
- Review
- 110 days
- Class
- Class II
- Product code
- MEG
- Recalls
- 1
- Predicates
- 0
22 later devices descend from it, 4 citing it directly.
- This deviceK012121 Secureguard Retractable Safety SyringeSafegard Medical Products, Inc. · 2001
- Descendant · cites it directly · 15 of its ownK031594 Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety…M.K. Meditech Co., Ltd. · 2003
- Descendant · 2 generations on · 8 of its ownK050131 Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005
- Descendant · 3 generations on · 5 of its ownK152808 U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016
- Descendant · 2 generations on · 4 of its ownK042500 Duopross SyringesDuopross Meditech Corporation · 2005
- Descendant · cites it directly · 4 of its ownK030976 Careo Retractable Safety SyringeLife-Shield Products, Inc. · 2003
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K031594Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe TrayM.K. Meditech Co., Ltd. · 2003 · cites it directly15descendants
- K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005 · 2 generations on8descendants
- K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016 · 3 generations on5descendants
- K042500Duopross SyringesDuopross Meditech Corporation · 2005 · 2 generations on4descendants
- K030976Careo Retractable Safety SyringeLife-Shield Products, Inc. · 2003 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012121 | Secureguard Retractable Safety Syringe | Safegard Medical Products, Inc. | 2001 | — |
| +1 | K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray | M.K. Meditech Co., Ltd. | 2003 | — |
| +2 | K050131 | Insosafe Bak'snap Retractable Insulin Safety Syringe | M.K. Meditech Co., Ltd. | 2005 | — |
| +3 | K152808 | U&U Insulin Syringe with/without Safety Retractable Device | U&U Medical Technology Co, Ltd. | 2016 | — |
| +2 | K042500 | Duopross Syringes | Duopross Meditech Corporation | 2005 | — |
| +1 | K030976 | Careo Retractable Safety Syringe | Life-Shield Products, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | — | SOLOGARD® Locking Plus Syringe Named without a submission number |
What descends from it? (22)
See all 224 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2010 | Not classified | Z-1800-2010 | Other | Syringe Defects. Group 1 syringes: The plunger pull out force was below specification. Group 2 syringes: The needle length is out of specification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031594 (M.K. Meditech Co., Ltd., 2003) has gone furthest, with 15 descendants of its own.
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 intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012121: Secureguard Retractable Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012121
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026