510(k) · Cleared
ClearedXtract Syringe Key System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xtract Solutions · FMF Syringe, Piston
Cleared on Nov 10, 2011 as substantially equivalent to K091200 (Xtract Solutions, LLC, 2009) after a 73-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Nov 10, 2011
- Review
- 73 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883311 (1988). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K091200 | Xtract Syringe KeysSummary page 2…Solutions 3mL Syringe Keys as an accessory to piston hypodermic syringes such as the following predicate device: 4.4.1 Xtract Solutions Syringe Keys, K091200, SE 08/21/2009, manufactured by Xtract Solutions, Portland, OR. 4.4.2 Xtract… | 2009 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 20.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 product family of Xtract Solutions Syringe Keys are indicated as accessories provided for specified commercially available piston hypodermic syringes (for medical purposes) which are designed to control the distance the syringe plunger can be drawn through the syringe barrel and to facilitate the user in obtaining accurate, consistent and precise volumetric draws from vials containing liquids such as vaccinations, allergenic extracts and other…
Read the full statement (219 words)
The product family of Xtract Solutions Syringe Keys are indicated as accessories provided for specified commercially available piston hypodermic syringes (for medical purposes) which are designed to control the distance the syringe plunger can be drawn through the syringe barrel and to facilitate the user in obtaining accurate, consistent and precise volumetric draws from vials containing liquids such as vaccinations, allergenic extracts and other medications. The Syringe Keys (available for lmL and/or 3 mL hypodermic syringes) are designed as an accessory only for the following syringes:
1 mL syringes:
1 mL Terumo SurSaver Mixing Syringes (SSO1A2313T) and/or
1 mL Greer Optimix (GROM-23) Sur-Saver Mixing Syringes.
3 mL syringes:
3 mL VanishPoint (RTI 10311) Syringes, 23g xl1
3 mL BID SafetyGlidle (80305905) Syringes, 23g x 1V
3 mL BID Integra (BD305271) Syringes 23g x 1"
3 mL BID Precision Glide (80309576) Syringes 20g x 1,,
The device assists the user in withdrawing precise and accurate liquid volume withdraws from a vial. The Syringe Keys do not facilitate or assist the user with iniectinci the contents of the hypodermic syringe.
The Syringe Keys can be used by medical personnel as well as individuals who are not medical professionals; but, have been instructed in their use.
Syringe Keys will be available for specified piston hypodermic syringe models manufactured by designated syringe manufacturers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112475: Xtract Syringe Key System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112475
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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