510(k) · Cleared
ClearedComcaset Safety IV Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pitango Medical, Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 8, 2006 as substantially equivalent to K984059 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1999) after a 15-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Aug 8, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984059 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK984059 Angiocath Autoguard Catheter, Insyte Autoguard CatheterBd Becton Dickinson Vacutainer Systems Preanalytic · 1999
- This deviceK062108 Comcaset Safety IV CatheterPitango Medical, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK070020 Comcaset-P Safety IV CatheterPitango Medical, Ltd. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070020Comcaset-P Safety IV CatheterPitango Medical, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984059 | Angiocath Autoguard Catheter, Insyte Autoguard Catheter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999 | — |
| 0 (this device) | K062108 | Comcaset Safety IV Catheter | Pitango Medical, Ltd. | 2006 | — |
| +1 | K070020 | Comcaset-P Safety IV Catheter | Pitango Medical, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 FOZ? 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? (1)
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 |
|---|---|---|---|
| * | K984059 | Angiocath Autoguard Catheter, Insyte Autoguard CatheterSummary page 3…me principle of operation as the Insyte Tm Autoguard TM Shielded IV Catheter form Becton-Dickinson Infusion Therapy Systems Inc in Sandy, Utah, cleared under 5 10(k) no. K984059. The main technological difference between ComCaSet Safety IV Catheter and the predicate devices is the release element of the ne… | 1999 |
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 |
|---|---|---|---|
| K070020 | Comcaset-P Safety IV Catheter | 2007 | 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?
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.
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 ComCaSet Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet Safety IV Catheter may be used for any patient population with consideration given to adequacy of the vascular anatomy appropriateness for the solution being administered and duration of the therapy. The ComCaSet Safety IV Catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the catheter hub and needle assembly components are withdrawn, the user activates the shielding mechanism and the needle retracts into the shielding tube.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062108: Comcaset Safety IV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062108
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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