510(k) · Cleared
ClearedPump Alignment Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Caina Medical Co.,Ltd · FMF Syringe, Piston
Cleared on Jul 21, 2022 as substantially equivalent to K980987 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) after a 178-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jul 21, 2022
- Review
- 178 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980987 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980987 Becton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- This deviceK220184 Pump Alignment SyringeJiangsu Caina Medical Co.,Ltd · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980987 | Becton Dickinson Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 15 |
| 0 (this device) | K220184 | Pump Alignment Syringe | Jiangsu Caina Medical Co.,Ltd | 2022 | — |
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 |
|---|---|---|---|
| * | K980987 | Becton Dickinson SyringeSummary page 5…ould maintain the sterility of the device during the shelf life of five years. 5. Identification of Predicate Device Predicate Device 510(k) Number: K980987 Product Name: Becton Dickinson Single Use Hypodermic Syringes 6. Non-Clinical Test Conclusion Non clinical tests… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 a recall.
- 17 other devices also cite its predicate K980987.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Pump Alignment Syringe is intended for use by healthcare professionals for injection of fluids for medical purposes into patients of all ages, including neonates in a controlled manner with compatible infusion pumps. The Pump Alignment Syringe can also be used for manual injection of fluids for medical purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220184: Pump Alignment Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220184
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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