510(k) · Cleared
ClearedFirmgrip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexicath, Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Oct 16, 2008 as substantially equivalent to K063363 (Flexicath, Ltd., 2007) after a 210-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Oct 16, 2008
- Review
- 210 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930473 (1994). 7 ancestors in all, the oldest K823553 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK930473 Onecath L-Cath Catheter SystemLuther Medical Products, Inc. · 1994
- 3 generations backK980090 Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)Luther Medical Products, Inc. · 1998
- 2 generations backK992424 Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length)…Plastimed Laboratoire Pharmaceutique · 2000
- 1 generation backK063363 Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007
- This deviceK080793 FirmgripFlexicath, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK092629 SNM FirmgripFlexicath, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK111939 M/29TM - Pressure InjectableFlexicath, Ltd. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930473 | Onecath L-Cath Catheter System | Luther Medical Products, Inc. | 1994 | — |
| −3 | K980090 | Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM) | Luther Medical Products, Inc. | 1998 | — |
| −2 | K992424 | Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models… | Plastimed Laboratoire Pharmaceutique | 2000 | — |
| −1 | K063363 | Firmgrip Peripherally Inserted Catheter Device | Flexicath, Ltd. | 2007 | — |
| 0 (this device) | K080793 | Firmgrip | Flexicath, Ltd. | 2008 | — |
| +1 | K092629 | SNM Firmgrip | Flexicath, Ltd. | 2009 | — |
| +1 | K111939 | M/29TM - Pressure Injectable | Flexicath, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K063363 | Firmgrip Peripherally Inserted Catheter DeviceSummary page 2…- Peripherally Inserted Catheter Device is substantially equivalent to the original FirmGrip TM Peripherally Inserted Catheter Device, cleared under 510(k) number K063363. Device description: The FirmGrip TM peripherally inserted catheter includes a typical midline catheter encapsulated in a… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K092629 (Flexicath, Ltd., 2009) has gone furthest, with 1 descendant of its own.
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. 2008, 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 FirmGrip TM Peripherally Inserted Catheter Device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080793: Firmgrip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080793
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