510(k) · Cleared
Recalled · Class II · 2026High Pressure Sets-400 Psi
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 Dec 17, 2010 as substantially equivalent to K061285 (Cardinal Health, Alaris Products, 2006) and 2 other predicates after a 291-day review. Its family tree reaches back 2 generations to 1994. It has been recalled 8 times.
- Decided
- Dec 17, 2010
- Review
- 291 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 8
- Predicates
- 3
Its longest line of descent runs back 2 generations to K911884 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911884 | Advance Pressure Monitor/High Pressure Lines | Advance Medical Designs, Inc. | 1994 | — |
| −1 | K963749 | High Pressure Injection Lines | Maxxim Medical | 1996 | — |
| 0 (this device) | K100576 | High Pressure Sets-400 Psi | Icu Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2006 | 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 FPA? 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? (3)
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 |
|---|---|---|---|
| * | K061285 | Smartsite Needle Free Valve Administration SetsSummary page 1…e: Primary 2] CFR 880.5440, Class II Device, 80FPA Secondary 21 CFR 870.4290, Class 11 Device, 74DTL Legally Marketed Predicate Devices for Substantial Equivalence: *K061285 — Smart Site Valve Sets — Cardinal Health, Inc. *K941978 — High Pressurc Tubing, — Abbott Labs (submission acquired by ICU Medica… | 2006 |
| * | K941978 | High Pressure TubingSummary page 1…ndary 21 CFR 870.4290, Class 11 Device, 74DTL Legally Marketed Predicate Devices for Substantial Equivalence: *K061285 — Smart Site Valve Sets — Cardinal Health, Inc. *K941978 — High Pressurc Tubing, — Abbott Labs (submission acquired by ICU Medical Inc.) *K963749 - High Pressure Injection Line, Maxxim M… | 1994 |
| * | K963749 | High Pressure Injection LinesSummary page 1…stantial Equivalence: *K061285 — Smart Site Valve Sets — Cardinal Health, Inc. *K941978 — High Pressurc Tubing, — Abbott Labs (submission acquired by ICU Medical Inc.) *K963749 - High Pressure Injection Line, Maxxim Medical, Inc. Rationale for SE: The ICU Medical High Pressure Sets arc substantially cqu… | 1996 |
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 |
|---|---|---|---|---|
| May 12, 2026 | Class II | Z-3160-2026 | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration… |
| Aug 1, 2022 | Class II | Z-1720-2022 | Process control | Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
| Jul 6, 2020 | Class II | Z-0193-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
| Jul 6, 2020 | Class II | Z-0192-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
| Jul 6, 2020 | Class II | Z-0197-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
| Jul 6, 2020 | Class II | Z-0201-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
| Jul 6, 2020 | Class II | Z-0204-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
| Oct 4, 2019 | Class II | Z-1916-2020 | Mixed-up of materials/components | There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 3 other devices also cite its predicate K061285.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media {at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation…
Read the full statement (122 words)
The high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media {at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation of ICU proprietary connectors such as the CLAVE; MicroCLAVE; Y-CLAVE; and CLC2000 with the extension sets, allows for needleless connectivity to other devices via unlversal luer connection. The maximum pressure is 400 psi and other ancillary devices must also be rated for pressure up to 400 psi.
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/K100576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100576: High Pressure Sets-400 Psi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100576
Report an extraction error
Are you the manufacturer?
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