510(k) · Cleared
Cleared1BD Soloshot IX Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · FMF Syringe, Piston
Cleared on Oct 28, 2004 as substantially equivalent to K883955 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1988) after a 3-day review. Its family tree reaches back 1 generation to 1988. 8 later devices descend from it.
- Decided
- Oct 28, 2004
- Review
- 3 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883955 (1988). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK883955 Single-Fil (TM) SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
- This deviceK042934 1BD Soloshot IX SyringeBecton, Dickinson & CO · 2004
- Descendant · cites it directly · 5 of its ownK201234 BD SoloShot Mini Syringe/ BD Auto Disable SyringeBecton, Dickinson and Company · 2020
- Descendant · 2 generations on · 2 of its ownK210464 Auto Disable SyringeAnhui Tiankang Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK212920 Sterile Safety Syringe with Needle for Single Use, Sterile Safety…Shandong Weigao Group Medical Polymer Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK091377 BD Flu+ SyringeBecton, Dickinson & CO · 2009
- Descendant · 3 generations on · 0 of its ownK260514 Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle…CMT Health PTE., Ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K201234BD SoloShot Mini Syringe/ BD Auto Disable SyringeBecton, Dickinson and Company · 2020 · cites it directly5descendants
- K210464Auto Disable SyringeAnhui Tiankang Medical Technology Co., Ltd. · 2021 · 2 generations on2descendants
- K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for…Shandong Weigao Group Medical Polymer Co., Ltd. · 2022 · 2 generations on1descendant
- K091377BD Flu+ SyringeBecton, Dickinson & CO · 2009 · cites it directly1descendant
- K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883955 | Single-Fil (TM) Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988 | — |
| 0 (this device) | K042934 | 1BD Soloshot IX Syringe | Becton, Dickinson & CO | 2004 | — |
| +1 | K201234 | BD SoloShot Mini Syringe/ BD Auto Disable Syringe | Becton, Dickinson and Company | 2020 | — |
| +2 | K210464 | Auto Disable Syringe | Anhui Tiankang Medical Technology Co., Ltd. | 2021 | — |
| +2 | K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic… | Shandong Weigao Group Medical Polymer Co., Ltd. | 2022 | — |
| +1 | K091377 | BD Flu+ Syringe | Becton, Dickinson & CO | 2009 | — |
| +3 | K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™… | CMT Health PTE., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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 16.2 · 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 |
|---|---|---|---|
| * | K883955 | Single-Fil (TM) SyringeSummary page 1…BD Single-Fil Syringe Manufactured by: Becton Dickdnson and Company 3. Device Description: The Predicate Device, the BD Single-Fil M Syringe (K883955) is a standard 3-piece T piston syringe with a permanently attached needle and with… | 1988 |
What descends from it? (8)
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?
- Its one ancestor has no recall.
- Of its descendants, K201234 (Becton, Dickinson and Company, 2020) has gone furthest, with 5 descendants of its own.
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 SoloShotTM IX Syringes are intended for the aspiration and injection of fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042934 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042934: 1BD Soloshot IX Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042934
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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