510(k) · Cleared
Recalled · Class II · 2013Becton Dickinson Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · MEG Syringe, Antistick
Cleared on Oct 1, 1999 after a 49-day review. The FDA summary names its predicate without a number. 10 later devices descend from it. It has been recalled 6 times.
- Decided
- Oct 1, 1999
- Review
- 49 days
- Class
- Class II
- Product code
- MEG
- Recalls
- 6
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK992734 Becton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1999
- Descendant · cites it directly · 8 of its ownK050131 Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005
- Descendant · 2 generations on · 5 of its ownK152808 U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016
- Descendant · 3 generations on · 2 of its ownK202570 Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd. · 2021
- Descendant · 4 generations on · 1 of its ownK220061 Safety Insulin SyringesBerpu Medical Technology Co., Ltd. · 2022
- Descendant · 5 generations on · 0 of its ownK230061 Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005 · cites it directly8descendants
- K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016 · 2 generations on5descendants
- K202570Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd. · 2021 · 3 generations on2descendants
- K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd. · 2022 · 4 generations on1descendant
- K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992734 | Becton Dickinson Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999 | — |
| +1 | K050131 | Insosafe Bak'snap Retractable Insulin Safety Syringe | M.K. Meditech Co., Ltd. | 2005 | — |
| +2 | K152808 | U&U Insulin Syringe with/without Safety Retractable Device | U&U Medical Technology Co, Ltd. | 2016 | — |
| +3 | K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021 | — |
| +4 | K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | 2022 | — |
| +5 | K230061 | Insulin Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | — | Becton Dickinson Syringes Named without a submission number | |
| * | — | SafetyGlide™ Needle Named without a submission number |
What descends from it? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2013 | Class II | Z-1577-2013 | Process control | There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe. |
| Jul 24, 2006 | Not classified | Z-1525-06 | Other | BD received reports of needle assembly disengagement from the syringe. |
| Oct 25, 2005 | Not classified | Z-0403-06 | Other | Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick. |
| Oct 25, 2005 | Not classified | Z-0402-06 | Other | Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick. |
| Oct 25, 2005 | Not classified | Z-0404-06 | Other | Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick. |
| Oct 25, 2005 | Not classified | Z-0405-06 | Other | Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050131 (M.K. Meditech Co., Ltd., 2005) has gone furthest, with 8 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 | — |
What is it indicated for?
The Becton Dickinson SafetyGlide™ Syringes are used for a variety of injections and aspirations of fluid from vials, ampules and parts of the body below the surface of the skin. The insulin syringe has scale lines in insulin units and is typically used for insulin injections. The allergy syringes come in test and treatment versions. The allergy test syringe has an intra-dermal bevel for intra-dermal injections. The allergy treatment syringe has a regular…
Read the full statement (140 words)
The Becton Dickinson SafetyGlide™ Syringes are used for a variety of injections and aspirations of fluid from vials, ampules and parts of the body below the surface of the skin. The insulin syringe has scale lines in insulin units and is typically used for insulin injections. The allergy syringes come in test and treatment versions. The allergy test syringe has an intra-dermal bevel for intra-dermal injections. The allergy treatment syringe has a regular bevel which is typically used for subcutaneous injections. The tuberculin syringe has a regular bevel which can be used for any of the 3 types of common injections (intra-dermal, intra-muscular or subcutaneous).
The SafetyGlide™ Syringe contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
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/K992734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992734: Becton Dickinson Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992734
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