510(k) · Cleared
ClearedXpresse Injection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nordson Efd · FMF Syringe, Piston
Cleared on Jun 30, 2009 as substantially equivalent to K820164 (Sterling Drug, Inc., 1982) and 1 other predicate after a 208-day review. Its family tree reaches back 2 generations to 1982. 1 later device descends from it.
- Decided
- Jun 30, 2009
- Review
- 208 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K820164 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK820164 Empty Sterile CarpujectSterling Drug, Inc. · 1982
- 1 generation backK063180 Isecure Syringe Cartridge HolderHospira, Inc. · 2006
- This deviceK083583 Xpresse Injection SystemNordson Efd · 2009
- Descendant · cites it directly · 0 of its ownK131963 Tautona Injector DeviceTautona Group, LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K131963Tautona Injector DeviceTautona Group, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820164 | Empty Sterile Carpuject | Sterling Drug, Inc. | 1982 | — |
| −1 | K063180 | Isecure Syringe Cartridge Holder | Hospira, Inc. | 2006 | — |
| 0 (this device) | K083583 | Xpresse Injection System | Nordson Efd | 2009 | — |
| +1 | K131963 | Tautona Injector Device | Tautona Group, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K820164 | Empty Sterile CarpujectSummary page 1…iston (Syringe Assist, Syringe Accessory) Predicate Device The XPRESSE Assist Device is substantially equivalent to the Carpuject® Cartridge Syringe Holder Accessory, K820164, and the iSecure Syringe Cartridge Holder, K063180, regarding indication for use, intended use, and operating principle. The XPR… | 1982 |
| * | K063180 | Isecure Syringe Cartridge HolderSummary page 1…te Device The XPRESSE Assist Device is substantially equivalent to the Carpuject® Cartridge Syringe Holder Accessory, K820164, and the iSecure Syringe Cartridge Holder, K063180, regarding indication for use, intended use, and operating principle. The XPRESSE Assist Device does not raise new questions ass… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131963 | Tautona Injector Device | 2013 | 0 |
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 27 years and passes through 3 companies; a new generation was cleared every 24.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131963 (Tautona Group, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K820164.
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 XPRESSE Assist Device is a syringe assist device intended for use in the administration of sterile materials under aseptic conditions in accordance with the best judgment of the clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083583: Xpresse Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083583
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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