510(k) · Cleared
Recalled · 2008BD Integra Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Feb 7, 2003 as substantially equivalent to K980580 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) and 2 other predicates after a 91-day review. Its family tree reaches back 1 generation to 1998. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 7, 2003
- Review
- 91 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K980069 (1998). 3 ancestors in all. 16 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK980069 Vanishpoint SyringeRetractable Technologies, Inc. · 1998
- This deviceK023752 BD Integra SyringeBd · 2003
- Descendant · cites it directly · 5 of its ownK132120 WTF Secura Syringe and NeedleBeijing Wantefu Medical Apparatus Co., Ltd. · 2013
- Descendant · cites it directly · 4 of its ownK182274 Orbit Subretinal Delivery SystemOrbit Biomedical, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK200325 Orbit Subretinal Delivery SystemOrbit Biomedical · 2020
- Descendant · 2 generations on · 3 of its ownK143497 Safety Auto-Disable Syrine with Needle (Auto-Lock)Guangdong Intmed Medical Appliance Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK203264 MicroDose InjectorMedone Surgical, Inc. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K132120WTF Secura Syringe and NeedleBeijing Wantefu Medical Apparatus Co., Ltd. · 2013 · cites it directly5descendants
- K182274Orbit Subretinal Delivery SystemOrbit Biomedical, Inc. · 2018 · cites it directly4descendants
- K200325Orbit Subretinal Delivery SystemOrbit Biomedical · 2020 · 2 generations on3descendants
- K143497Safety Auto-Disable Syrine with Needle (Auto-Lock)Guangdong Intmed Medical Appliance Co., Ltd. · 2015 · 2 generations on3descendants
- K203264MicroDose InjectorMedone Surgical, Inc. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980069 | Vanishpoint Syringe | Retractable Technologies, Inc. | 1998 | — |
| 0 (this device) | K023752 | BD Integra Syringe | Bd | 2003 | — |
| +1 | K132120 | WTF Secura Syringe and Needle | Beijing Wantefu Medical Apparatus Co., Ltd. | 2013 | — |
| +1 | K182274 | Orbit Subretinal Delivery System | Orbit Biomedical, Inc. | 2018 | — |
| +2 | K200325 | Orbit Subretinal Delivery System | Orbit Biomedical | 2020 | — |
| +2 | K143497 | Safety Auto-Disable Syrine with Needle (Auto-Lock) | Guangdong Intmed Medical Appliance Co., Ltd. | 2015 | — |
| +3 | K203264 | MicroDose Injector | Medone Surgical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K980580 | Becton Dickinson SyringesSummary page 1…: 201-847-45 13 Fax: 201-847-4855 E-mail: [email protected] 2. Device Name: BD IntegraTMlrnl Syringe 3. Predicate Devices: BD Insulin Syringe, Latex Free K980580 BD Spring Based Syringe KO1 1103 RTI VanishPoints Syringe K980069 4. Product Descrip… | 1998 |
| * | K011103 | BD Spring Based Syringe | 2001 |
| * | K980069 | Vanishpoint SyringeSummary page 1…ringe 3. Predicate Devices: BD Insulin Syringe, Latex Free K980580 BD Spring Based Syringe KO1 1103 RTI VanishPoints Syringe K980069 4. Product Description/Function: 4.1 Description: Single-use syringe with a needle protection system. Needle sizes: 30… | 1998 |
What descends from it? (16)
See all 165 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 |
|---|---|---|---|---|
| Nov 24, 2008 | Not classified | Z-0619-2009 | Incorrect or no expiration date | Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03. |
| Jan 27, 2007 | Not classified | Z-0582-2007 | Other | The needle becomes detached from the hub/syringe |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The BD IntegraTM Syringe is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. It is not intended to be used for phlebotomy. The insulin syringe has scale lines in insulin units and is used for insulin injections. The tuberculin syringe can be used for any of the 3 types of common injections (intra-dermal, intra-muscular or subcutaneous). The BD IntegraTMlml Syringe has a permanently…
Read the full statement (133 words)
The BD IntegraTM Syringe is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. It is not intended to be used for phlebotomy. The insulin syringe has scale lines in insulin units and is used for insulin injections. The tuberculin syringe can be used for any of the 3 types of common injections (intra-dermal, intra-muscular or subcutaneous).
The BD IntegraTMlml Syringe has a permanently attached needle. The BD IntegraTM1nil Syringe contains a tool used to cut through the hub and stopper allowing the needle to become retracted inside the plunger rod of the syringe after use. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needlehyringe combination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023752: BD Integra Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023752
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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