510(k) · Cleared
ClearedI-Port Advance Injection Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unomedical A/S · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Feb 16, 2012 as substantially equivalent to K052389 (Patton Medical Devices, 2005) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 1997. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 16, 2012
- Review
- 13 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972135 (1997). 8 ancestors in all, the oldest K881767 (1988). No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK972135 Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 1997 · Recalled
- 1 generation backK032854 Unomedical Monica Infusion SetUnomedical A/S · 2003 · Recalled
- This deviceK120337 I-Port Advance Injection PortUnomedical A/S · 2012
Class I recalls in this family
- K011071 Paradigm Quick-Set Infusion Set2 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972135 | Maersk Medical Pureline Comfort Subcutaneous Infusion Set | P/L Biomedical | 1997 | 16 |
| −1 | K032854 | Unomedical Monica Infusion Set | Unomedical A/S | 2003 | 1 |
| 0 (this device) | K120337 | I-Port Advance Injection Port | Unomedical A/S | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 1 |
| 2003 | 1 | 0 |
| 2005 | 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.
1 device in this family has 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 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 |
|---|---|---|---|
| * | K052389 | I-PORTSummary page 1…bers for the device include 020110, 020210, 020102 and 020202. These are the same indications previously cleared for the predicate i-port® injection port (K052389) 5.4 Predicate Devices The i-port AdvanceTM is substantially equivalent to: Patton Medical Devices i-port®H inj… | 2005 |
| * | K032854 | Unomedical Monica Infusion SetSummary page 1…s The i-port AdvanceTM is substantially equivalent to: Patton Medical Devices i-port®H injection port (K052389) Unomedical A/S InsetTm Infusion Set (K032854) 5.5 Device Description The i-port AdvanceTM injection port was designed and developed through a technological collabo… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K011071Paradigm Quick-Set Infusion SetMaersk Medical A/S · 2001 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- 4 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The i-port Advance™ injection port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. The i-port Advance™ may be used on a wide range of patients, including adults and children. Model numbers for the device include 020110, 020210, 020102 and 020202.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120337: I-Port Advance Injection Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120337
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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