510(k) · Cleared
Recalled · 2005Medcomp Z-Cath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jan 26, 2001 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 26, 2001
- Review
- 57 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 2
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK003682 Medcomp Z-CathMedical Components, Inc. · 2001
- Descendant · cites it directly · 9 of its ownK091586 Vascu-Picc and Midline Catheters, Single, Double and Triple LumenMedcomp · 2009
- Descendant · cites it directly · 3 of its ownK063363 Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK123292 T3Medcomp · 2013
- Descendant · 2 generations on · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013
- Descendant · 2 generations on · 2 of its ownK080793 FirmgripFlexicath, Ltd. · 2008
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K091586Vascu-Picc and Midline Catheters, Single, Double and Triple LumenMedcomp · 2009 · cites it directly9descendants
- K063363Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007 · cites it directly3descendants
- K123292T3Medcomp · 2013 · 2 generations on2descendants
- K130034Uni-PiccHealth Line International Corporation · 2013 · 2 generations on2descendants
- K080793FirmgripFlexicath, Ltd. · 2008 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003682 | Medcomp Z-Cath | Medical Components, Inc. | 2001 | — |
| +1 | K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen | Medcomp | 2009 | — |
| +1 | K063363 | Firmgrip Peripherally Inserted Catheter Device | Flexicath, Ltd. | 2007 | — |
| +2 | K123292 | T3 | Medcomp | 2013 | — |
| +2 | K130034 | Uni-Picc | Health Line International Corporation | 2013 | — |
| +2 | K080793 | Firmgrip | Flexicath, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 15, 2005 | Not classified | Z-0104-06 | Other | The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F |
| Sep 15, 2005 | Not classified | Z-0103-06 | Other | The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091586 (Medcomp, 2009) has gone furthest, with 9 descendants of its own.
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.
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) | — |
https://510kreport.com/device/K003682 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003682: Medcomp Z-Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003682
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026