510(k) · Cleared
ClearedTMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78 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 Sep 22, 2004 as substantially equivalent to K031062 (Taiject Medical Device Co., Ltd., 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Sep 22, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K022278 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK022278 TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)Taiject Medical Device Co., Ltd. · 2002
- 2 generations backK023458 TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)Taiject Medical Device Co., Ltd. · 2002
- 1 generation backK031062 TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100…Taiject Medical Device Co., Ltd. · 2003
- This deviceK042426 TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100…Taiject Medical Device Co., Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022278 | TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML) | Taiject Medical Device Co., Ltd. | 2002 | — |
| −2 | K023458 | TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML) | Taiject Medical Device Co., Ltd. | 2002 | — |
| −1 | K031062 | TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series… | Taiject Medical Device Co., Ltd. | 2003 | — |
| 0 (this device) | K042426 | TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78… | Taiject Medical Device Co., Ltd. | 2004 | — |
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 |
|---|---|---|---|
| * | K031062 | TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin)Summary page 3…ally Marketed Device): Legally Marketed Device: FAllI Series lml/FA51 Series U-lO0 Insulin/FA71 Series Tuberculin) with 510K number K03 1062 and FA12 Series 3 ml/FA13 Series 5 ml with 510K number K022278 4. DEVICE DESCRIPTION The TMD… | 2003 |
| * | K022278 | TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)Summary page 3…llI Series lml/FA51 Series U-lO0 Insulin/FA71 Series Tuberculin) with 510K number K03 1062 and FA12 Series 3 ml/FA13 Series 5 ml with 510K number K022278 4. DEVICE DESCRIPTION The TMD TN{ O.5ml Safety Syringe (FA18 Series O.5mI/FA58 Series U-100 Insulin/… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 years and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
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 T M 0.5ml Insulin Safety Syringe (FA58 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin.
This syringe above incorporates a safety.feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.
The TMD TM 0.5ml Safety Syringe (FA18 Series 0.5ml) is intended for injection of fluids into the body after the aspiration of fluid.
The TMD TM 0.5ml Tuberculin Safety Syringe (FA78 Series Tuberculin) is intended intra-dermal of Tuberculin.
All these two syringes above incorporate a safety feature that is designed to aid the reduction of needle stick 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/K042426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042426: TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78 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/K042426
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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