510(k) · Cleared
ClearedTMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiject Medical Device Co., Ltd. · MEG Syringe, Antistick
Cleared on May 2, 2003 as substantially equivalent to K022278 (Taiject Medical Device Co., Ltd., 2002) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- May 2, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022278 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK022278 TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)Taiject Medical Device Co., Ltd. · 2002
- 1 generation backK023458 TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)Taiject Medical Device Co., Ltd. · 2002
- This deviceK031062 TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100…Taiject Medical Device Co., Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK042426 TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100…Taiject Medical Device Co., Ltd. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042426TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78 Series…Taiject Medical Device Co., Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022278 | TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML) | Taiject Medical Device Co., Ltd. | 2002 | — |
| −1 | K023458 | TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML) | Taiject Medical Device Co., Ltd. | 2002 | — |
| 0 (this device) | K031062 | TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series… | Taiject Medical Device Co., Ltd. | 2003 | — |
| +1 | K042426 | TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78… | Taiject Medical Device Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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.
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 |
|---|---|---|---|
| * | K022278 | TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)Summary page 2…ti-Stick Syringe (MEG) 3. Predicate Device (Legally Marketed Device): Legally Marketed Device: TMD™ Safety Syringe (FA12 Series 3 mI/FA13 Series 5 ml) with 510K number K022278. 4. DEVICE DESCRIPTION The TMD™ 1ml Safety Syringe (FA11 Series 1mI/FA51 Series U-100 Insulin / FA71 Series Tuberculin) is a si… | 2002 |
| * | K023458 | TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)Summary page 3…device, TMD™ Safety Syringe (FA12 Series 3 mI/FA13 Series 5 ml) with 510K number K022278 and TMD™ Safety Syringe (FA14 Series 10 mV/FA15 Series 20 ml) with 510K number K023458. 7. PERFORMANCE DATA Performance data has been generated in compliance with the design control requirement and appropriate sta… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042426 | TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78 Series… | 2004 | 0 |
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 1 year and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K042426 (Taiject Medical Device Co., Ltd., 2004) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K022278.
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 TMD™ 1ml Safety Syringe (FA11 Series 1ml) is intended for injection of fluids into the body after the aspiration of fluid.
The TMD™ 1ml Insulin Safety Syringe (FA51 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin.
The TMD™ 1ml Tuberculin Safety Syringe (FA71 Series Tuberculin) is intended for intra-dermal injection of Tuberculin.
All the three syringes above incorporate a safety feature that is designed to aid the reduction of needlestick injuries and the potential of syringe reuse.
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/K031062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031062: TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031062
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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