510(k) · Cleared
ClearedBiotop DJT-a Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotop Technology Co., Ltd. · MEG Syringe, Antistick
Cleared on May 11, 2004 as substantially equivalent to K020623 (M.K. Meditech Co., Ltd., 2002) and 1 other predicate after a 250-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it.
- Decided
- May 11, 2004
- Review
- 250 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000572 (2000). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- 2 generations backK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 1 generation backK022806 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- This deviceK032747 Biotop DJT-a Safety SyringeBiotop Technology Co., Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK041970 Biotop Hooksafe Safety Syringe, Models 0.5CC/ML, 1CC/ML, 3CC/ML…Biotop Technology Co., Ltd. · 2004
- Descendant · 2 generations on · 0 of its ownK062318 Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/MLBiotop Technology Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK060772 Manuel Saftey Syringe Parts 1 & 2Medsafe Asa · 2006
- Descendant · 2 generations on · 0 of its ownK043038 Biotop Hooksafe Luer-Lock Safety Syringe, Models 3CC/ML, 5CC/ML and…Biotop Technology Co., Ltd. · 2004
Most influential descendants
Showing 4 of 4 · See all- K041970Biotop Hooksafe Safety Syringe, Models 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML and 10CC/MLBiotop Technology Co., Ltd. · 2004 · cites it directly2descendants
- K062318Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/MLBiotop Technology Co., Ltd. · 2007 · 2 generations on0descendants
- K060772Manuel Saftey Syringe Parts 1 & 2Medsafe Asa · 2006 · cites it directly0descendants
- K043038Biotop Hooksafe Luer-Lock Safety Syringe, Models 3CC/ML, 5CC/ML and 10CC/MLBiotop Technology Co., Ltd. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| −2 | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −1 | K022806 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| 0 (this device) | K032747 | Biotop DJT-a Safety Syringe | Biotop Technology Co., Ltd. | 2004 | — |
| +1 | K041970 | Biotop Hooksafe Safety Syringe, Models 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML and… | Biotop Technology Co., Ltd. | 2004 | — |
| +2 | K062318 | Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/ML | Biotop Technology Co., Ltd. | 2007 | — |
| +1 | K060772 | Manuel Saftey Syringe Parts 1 & 2 | Medsafe Asa | 2006 | — |
| +2 | K043038 | Biotop Hooksafe Luer-Lock Safety Syringe, Models 3CC/ML, 5CC/ML and 10CC/ML | Biotop Technology Co., Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K020623 | Duopro Safety Syringe (Duopross)Summary page 1…: Antistick Syringe (MEG) 4. Predicate Device: Claim of Substantial Equivalence (SE) is made to M.K. Meditech Company's DuoPro Safety Syringe (DuoProSS TM) (K020623, K022806). 5. Device Description: The BIOTOP DJT-A Safety Syringe is a single-use hypodermic syringe that is very similar… | 2002 |
| * | K022806 | Duopro Safety Syringe (Duopross)Summary page 1…stick Syringe (MEG) 4. Predicate Device: Claim of Substantial Equivalence (SE) is made to M.K. Meditech Company's DuoPro Safety Syringe (DuoProSS TM) (K020623, K022806). 5. Device Description: The BIOTOP DJT-A Safety Syringe is a single-use hypodermic syringe that is very similar to a tra… | 2002 |
What descends from it? (4)
2 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)
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 4 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K041970 (Biotop Technology Co., Ltd., 2004) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K020623.
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 BIOTOP DJT-A Safety Syringe (3cc/mL) serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032747: Biotop DJT-a 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/K032747
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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