510(k) · Cleared
ClearedBD SoloShot Mini Syringe/ BD Auto Disable Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · FMF Syringe, Piston
Cleared on Jul 15, 2020 as substantially equivalent to K042934 (Becton, Dickinson & CO, 2004) after a 69-day review. Its family tree reaches back 2 generations to 1988. 5 later devices descend from it.
- Decided
- Jul 15, 2020
- Review
- 69 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883955 (1988). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK883955 Single-Fil (TM) SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
- 1 generation backK042934 1BD Soloshot IX SyringeBecton, Dickinson & CO · 2004
- This deviceK201234 BD SoloShot Mini Syringe/ BD Auto Disable SyringeBecton, Dickinson and Company · 2020
- Descendant · cites it directly · 2 of its ownK210464 Auto Disable SyringeAnhui Tiankang Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK212920 Sterile Safety Syringe with Needle for Single Use, Sterile Safety…Shandong Weigao Group Medical Polymer Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK260514 Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle…CMT Health PTE., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK234024 HWJECT Auto-disable syringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK231519 Revital CadyRevital Healthcare (Epz) Limited · 2023
Most influential descendants
Showing 5 of 5 · See all- K210464Auto Disable SyringeAnhui Tiankang Medical Technology Co., Ltd. · 2021 · cites it directly2descendants
- K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for…Shandong Weigao Group Medical Polymer Co., Ltd. · 2022 · cites it directly1descendant
- K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd. · 2026 · 2 generations on0descendants
- K234024HWJECT Auto-disable syringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2024 · 2 generations on0descendants
- K231519Revital CadyRevital Healthcare (Epz) Limited · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883955 | Single-Fil (TM) Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988 | — |
| −1 | K042934 | 1BD Soloshot IX Syringe | Becton, Dickinson & CO | 2004 | — |
| 0 (this device) | K201234 | BD SoloShot Mini Syringe/ BD Auto Disable Syringe | Becton, Dickinson and Company | 2020 | — |
| +1 | K210464 | Auto Disable Syringe | Anhui Tiankang Medical Technology Co., Ltd. | 2021 | — |
| +1 | K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic… | Shandong Weigao Group Medical Polymer Co., Ltd. | 2022 | — |
| +2 | K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™… | CMT Health PTE., Ltd. | 2026 | — |
| +2 | K234024 | HWJECT Auto-disable syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2024 | — |
| +2 | K231519 | Revital Cady | Revital Healthcare (Epz) Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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? (1)
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 |
|---|---|---|---|
| * | K042934 | 1BD Soloshot IX SyringeSummary page 4…e Classification Name: Piston Syringe; 21 CFR §880.5860 Regulatory Class: Class II device Product Code: FMF Predicate Device: BD SoloShot™ IX Syringe 510(k) Reference: K042934 Classification Name: Piston Syringe; 21 CFR §880.5860 Regulatory Class: Class II device Product Code: FMF Purpose of the Specia… | 2004 |
What descends from it? (5)
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 32 years and passes through 3 companies; a new generation was cleared every 16.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210464 (Anhui Tiankang Medical Technology Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K042934.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 SoloShot™ Mini Syringe/ BD Auto Disable Syringe is intended for aspiration and injection of
fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201234: BD SoloShot Mini Syringe/ BD Auto Disable Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201234
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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