510(k) · Cleared
ClearedFirmgrip Peripherally Inserted Catheter Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexicath, Ltd. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on May 7, 2007 as substantially equivalent to K003682 (Medical Components, Inc., 2001) and 2 other predicates after a 181-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- May 7, 2007
- Review
- 181 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K930473 (1994). 6 ancestors in all, the oldest K823553 (1983). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK930473 Onecath L-Cath Catheter SystemLuther Medical Products, Inc. · 1994
- 2 generations backK980090 Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)Luther Medical Products, Inc. · 1998
- 1 generation backK992424 Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length)…Plastimed Laboratoire Pharmaceutique · 2000
- This deviceK063363 Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK080793 FirmgripFlexicath, Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK092629 SNM FirmgripFlexicath, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK111939 M/29TM - Pressure InjectableFlexicath, Ltd. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930473 | Onecath L-Cath Catheter System | Luther Medical Products, Inc. | 1994 | — |
| −2 | K980090 | Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM) | Luther Medical Products, Inc. | 1998 | — |
| −1 | K992424 | Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models… | Plastimed Laboratoire Pharmaceutique | 2000 | — |
| 0 (this device) | K063363 | Firmgrip Peripherally Inserted Catheter Device | Flexicath, Ltd. | 2007 | — |
| +1 | K080793 | Firmgrip | Flexicath, Ltd. | 2008 | — |
| +2 | K092629 | SNM Firmgrip | Flexicath, Ltd. | 2009 | — |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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 LJS? 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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 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 |
|---|---|---|---|
| * | K003682 | Medcomp Z-CathSummary page 2…er device is substantially equivalent to a combination of the MedComp Z-Cath Catheter devices (manufactured by MedComp Corp. and the subject of 510(k) document no. K003682), the Seldiflex Central Venous Catheter (manufactured by Plastimed Laboratoire Pharmaceutique and the subject of 510(k) doc… | 2001 |
| * | K992424 | Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models 63244J20 &…Summary page 2…of 510(k) document no. K003682), the Seldiflex Central Venous Catheter (manufactured by Plastimed Laboratoire Pharmaceutique and the subject of 510(k) document no. K992424) and the Over the Needle (OTN) Splitable Catheter Introducer (manufactured by Teleflex Inc. and the subject of 510(k) document… | 2000 |
| * | K920908 | Over the Needle Splitable Catheter Assembly Type 1Summary page 2…f 510(k) document no. K992424) and the Over the Needle (OTN) Splitable Catheter Introducer (manufactured by Teleflex Inc. and the subject of 510(k) document no. K920908), in terms of intended use, indications for use, technological characteristics, performance and user interface. The predicate… | 1992 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080793 | Firmgrip | 2008 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K080793 (Flexicath, Ltd., 2008) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K003682.
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
The FirmGripTM 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/K063363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063363: Firmgrip Peripherally Inserted Catheter Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063363
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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