510(k) · Cleared
ClearedTMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)
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 12, 2002 after a 59-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Sep 12, 2002
- Review
- 59 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 5 citing it directly.
- This deviceK022278 TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)Taiject Medical Device Co., Ltd. · 2002
- Descendant · cites it directly · 2 of its ownK023458 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 · 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
- Descendant · cites it directly · 0 of its ownK040105 Yue Pfong Safety Syringe (3ML)Yue Pfong International Industrial Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK031909 Betec Retractable Safety Syringe (5ML)Betec Medical Science Co., Ltd. · 2003
Most influential descendants
Showing 5 of 5 · See all- K023458TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)Taiject Medical Device Co., Ltd. · 2002 · cites it directly2descendants
- 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 · cites it directly0descendants
- K040105Yue Pfong Safety Syringe (3ML)Yue Pfong International Industrial Co., Ltd. · 2004 · cites it directly0descendants
- K031909Betec Retractable Safety Syringe (5ML)Betec Medical Science Co., Ltd. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +1 | 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 | — |
| +1 | K040105 | Yue Pfong Safety Syringe (3ML) | Yue Pfong International Industrial Co., Ltd. | 2004 | — |
| +1 | K031909 | Betec Retractable Safety Syringe (5ML) | Betec Medical Science Co., Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023458 | TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML) | 2002 | 2 |
| K031062 | TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin) | 2003 | 1 |
| K042426 | TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78 Series… | 2004 | 0 |
| K040105 | Yue Pfong Safety Syringe (3ML) | 2004 | 0 |
| K031909 | Betec Retractable Safety Syringe (5ML) | 2003 | 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?
- Of its descendants, K023458 (Taiject Medical Device Co., Ltd., 2002) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K022278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022278: TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022278
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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