510(k) · Cleared
ClearedTMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)
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 Nov 7, 2002 as substantially equivalent to K022278 (Taiject Medical Device Co., Ltd., 2002) after a 23-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Nov 7, 2002
- Review
- 23 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022278 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK022278 TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)Taiject Medical Device Co., Ltd. · 2002
- This deviceK023458 TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)Taiject Medical Device Co., Ltd. · 2002
- Descendant · cites it directly · 1 of its ownK031062 TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100…Taiject Medical Device Co., Ltd. · 2003
- Descendant · 2 generations on · 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 2 of 2 · See all- K031062TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin)Taiject Medical Device Co., Ltd. · 2003 · cites it directly1descendant
- K042426TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78 Series…Taiject Medical Device Co., Ltd. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022278 | TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML) | Taiject Medical Device Co., Ltd. | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K022278 | TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)Summary page 1…needle 3. Predicate Device (Legally Marketed Device): Legally Marketed Device: TMDTMSafety Syringe (FA12 Series 3 ml/FA13 Series 5 ml) with 5 10K number K022278. 4. DEVICE DESCRIPTION The TMDTMSafety Syringe (FA14 Series 10ml/FA15 Series 20ml) is a sterile, sing… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031062 | TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin) | 2003 | 1 |
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?
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 TMDTM Safety Syringe (FA14 Series lOml/FA15 Series 20m1) is designed as an anti-stick syringe to reduce the risk of sharp injuries and the potential for syringe reuse and is a single use, disposable, manual retractable safety syringe which is intended for injection of fluids into and withdraw fluid from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023458: TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023458
Report an extraction error
Are you the manufacturer?
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