510(k) · Cleared
ClearedBD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Infusion Therapy Systems, Inc. · DBY Fab, Rhodamine, Antigen, Antiserum, Control
Cleared on Jan 2, 2002 after a 90-day review. The FDA summary names its predicate without a number. 130 later devices descend from it.
- Decided
- Jan 2, 2002
- Review
- 90 days
- Class
- Class I
- Product code
- DBY
- Recalls
- None
- Predicates
- 0
130 later devices descend from it, 4 citing it directly.
- This deviceK013304 BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded…Becton Dickinson Infusion Therapy Systems, Inc. · 2002
- Descendant · cites it directly · 100 of its ownK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- Descendant · 2 generations on · 91 of its ownK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- Descendant · 3 generations on · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- Descendant · 4 generations on · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- Descendant · 3 generations on · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 130 · See all- K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · cites it directly100descendants
- K070440BD Hypoint NeedleBecton, Dickinson & CO · 2007 · 2 generations on91descendants
- K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · 3 generations on78descendants
- K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · 4 generations on36descendants
- K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013304 | BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer | Becton Dickinson Infusion Therapy Systems, Inc. | 2002 | — |
| +1 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| +2 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| +3 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| +4 | K110421 | Disposable Insulin Syringe | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011 | — |
| +3 | K112057 | KDL Syringes and Needle | Shanghai Kindly Enterprise Dev. Group Co., | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 14 | 0 |
| 2022 | 18 | 0 |
| 2023 | 18 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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 DBY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | BD Introsyte™ Precision Introducer Named without a submission number | |
| * | — | BD Introsyte™ Autoguard™ Shielded Introducer Named without a submission number |
What descends from it? (130)
See all 1304 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | 2002 | 100 |
| K021094 | Introcan Safety IV Catheter | 2002 | 26 |
| K112887 | Upstream Needle Holder, Upstream Needle Holder with Shut-Off Connector | 2012 | 0 |
| K022099 | Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'S | 2002 | 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, K021475 (Bd, 2002) has gone furthest, with 100 descendants of its own.
How does its category compare?
All DBY devicesDBY Fab, Rhodamine, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DBY
FDA has decided no DBY device since 2007.
Median 510(k) review, days · DBY
Too few DBY 510(k)s in any year since 2007 to give a median.
Recalls per year · DBY
No recall names DBY since 2007.
Adverse event reports per year · DBY
1in 2007
MAUDE reports naming product code DBY, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To facilitate the placement of devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.
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/K013304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013304: BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013304
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026