510(k) · Cleared
Recalled · Class II · 2020Spiros
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Mar 20, 2007 after a 22-day review. The FDA summary names no predicate by number. 2 of the 17 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled once.
- Decided
- Mar 20, 2007
- Review
- 22 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 1
- Predicates
- 0
16 later devices descend from it, 4 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.
- This deviceK070532 SpirosIcu Medical, Inc. · 2007
- Descendant · cites it directly · 12 of its ownK082806 Spinning Spiros, Model CH-2000Icu Medical, Inc. · 2009 · Recalled
- 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
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K082806Spinning Spiros, Model CH-2000Icu Medical, Inc. · 2009 · cites it directly12descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070532 | Spiros | Icu Medical, Inc. | 2007 | — |
| +1 | K082806 | Spinning Spiros, Model CH-2000 | Icu Medical, Inc. | 2009 | 5 |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0699-2021 | 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?
- Of its descendants, K082806 (Icu Medical, Inc., 2009) has gone furthest, with 12 descendants of its own.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The SpirosTM is a single use, sterile, non-pvrogenic, swab-able, bi-directional valve device intended for use as an accessory to Intravascular Administration Set. The SpirosTM provides access of the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070532: Spiros.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070532
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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