510(k) · Cleared
Recalled · Class II · 2015Acacia Piston Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acacia, Inc. · FMF Syringe, Piston
Cleared on Oct 27, 2009 as substantially equivalent to K951871 (Baxa Corp., 1995) and 3 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1977. It has been recalled once.
- Decided
- Oct 27, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K771205 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- This deviceK092986 Acacia Piston SyringeAcacia, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| 0 (this device) | K092986 | Acacia Piston Syringe | Acacia, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1995 | 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? (4)
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 |
|---|---|---|---|
| * | K951871 | Piston SyringeSummary page 1…SIFICATION NAME: Piston Syringe DEVICE CLASSIFICATION: Class II PRODUCT CODE FMF PREDICATE DEVICES: Baxa Piston Syringe (K951871) Becton Dickinson Safety Syringe (K872820) Sherwood Medical Pisto… | 1995 |
| * | K872820 | Safety SyringeSummary page 1…s II PRODUCT CODE FMF PREDICATE DEVICES: Baxa Piston Syringe (K951871) Becton Dickinson Safety Syringe (K872820) Sherwood Medical Piston Syringe (K811965) Terumo Hypodermic Syri… | 1987 |
| * | K811065 | Piston Syringe Our reading of the summary gave K811965, FDA’s number for Visitec Needle Range (Gasterurology) (Visitec Co.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Sherwood Medical Piston Syringe”. | 1981 |
| * | K771205 | Hypodermic SyringeSummary page 1…n Dickinson Safety Syringe (K872820) Sherwood Medical Piston Syringe (K811965) Terumo Hypodermic Syringe (K771205) Substantially Equivalent To: The Acacia Piston Syringe is substantially equivalent in intended use, principal of operation and… | 1977 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 13, 2015 | Class II | Z-1262-2015 | Packaging | The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K951871.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Acacia Piston Syringe is indicated for the injection of fluids into, or withdrawal fluids from, the body. It is also used as a dispenser, a measuring device, and a fluid transfer device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092986: Acacia Piston Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092986
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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