510(k) · Cleared
Recalled · Class II · 2020Universal Vial Access Spike
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · FMF Syringe, Piston
Cleared on May 2, 2008 as substantially equivalent to K934561 (Icu Medical, Inc., 1994) and 1 other predicate after a 25-day review. Its family tree reaches back 1 generation to 1994. 2 of the 16 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled once.
- Decided
- May 2, 2008
- Review
- 25 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934561 (1994). 2 ancestors in all. 13 later devices descend from it, 1 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK934561 One Time Vial Access SpikeIcu Medical, Inc. · 1994
- This deviceK080989 Universal Vial Access SpikeIcu Medical, Inc. · 2008
- Descendant · cites it directly · 12 of its ownK081361 Chemoclave Cytotoxic Medication Preparation and Delivery System…Icu Medical, Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK131549 Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · Recalled (Class I)
- Descendant · 3 generations on · 9 of its ownK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- Descendant · 4 generations on · 3 of its ownK192866 Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · Recalled
- Descendant · 4 generations on · 1 of its ownK201422 Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · cites it directly12descendants
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 2 generations on10descendants
- K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015 · 3 generations on9descendants
- K192866Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · 4 generations on3descendants
- K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934561 | One Time Vial Access Spike | Icu Medical, Inc. | 1994 | — |
| 0 (this device) | K080989 | Universal Vial Access Spike | Icu Medical, Inc. | 2008 | — |
| +1 | K081361 | Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX | Icu Medical, Inc. | 2008 | Class I |
| +2 | K131549 | Chemolock, Chemolock Port | Icu Medical, Inc. | 2013 | Class I |
| +3 | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2015 | — |
| +4 | K192866 | Chemfort CSTD | Simplivia Healthcare, Ltd. | 2020 | 1 |
| +4 | K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2013 | 1 | 1 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
2 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K934561 | One Time Vial Access SpikeSummary page 1…on Name: Piston Syringe, Accessory 21 CFR 880.5860, Class II Device Product Code: FMF Legally Marketed Predicate Devices for Substantial Equivalence: *K934561 - One Time Vial Access - ICU Medical, Inc. *K934591 - Clave Vial Access Spike - ICU Medical, Inc. Rationale for SE: These combo… | 1994 |
| * | K934591 | Clave Vial Access SpikeSummary page 1…860, Class II Device Product Code: FMF Legally Marketed Predicate Devices for Substantial Equivalence: *K934561 - One Time Vial Access - ICU Medical, Inc. *K934591 - Clave Vial Access Spike - ICU Medical, Inc. Rationale for SE: These combo device is the vial access spike and the proprietary… | 1994 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081361 | Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX Class I | 2008 | 12 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2020 | Class II | Z-0710-2021 | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Accessory to a piston syringe for needleless access to sterile drug vials without the use of needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080989 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080989: Universal Vial Access Spike.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080989
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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