510(k) · Cleared
ClearedStatlock CV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venetec, Inc. · KMK Device, Intravascular Catheter Securement
Cleared on Sep 29, 1994 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Sep 29, 1994
- Review
- 91 days
- Class
- Class I
- Product code
- KMK
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK943147 Statlock CVVenetec, Inc. · 1994
- Descendant · cites it directly · 6 of its ownK082047 Securacath Catheter, Model SPK01Interrad Medical, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK083081 Modification to Securacath, Model: SPK01Interrad Medical, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK092306 Securacath UniversalInterrad Medical, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK120935 SecuracathInterrad Medical, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK180769 SecurAcathInterrad Medical, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K082047Securacath Catheter, Model SPK01Interrad Medical, Inc. · 2008 · cites it directly6descendants
- K083081Modification to Securacath, Model: SPK01Interrad Medical, Inc. · 2009 · 2 generations on5descendants
- K092306Securacath UniversalInterrad Medical, Inc. · 2010 · cites it directly4descendants
- K120935SecuracathInterrad Medical, Inc. · 2012 · 2 generations on3descendants
- K180769SecurAcathInterrad Medical, Inc. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943147 | Statlock CV | Venetec, Inc. | 1994 | — |
| +1 | K082047 | Securacath Catheter, Model SPK01 | Interrad Medical, Inc. | 2008 | — |
| +2 | K083081 | Modification to Securacath, Model: SPK01 | Interrad Medical, Inc. | 2009 | — |
| +1 | K092306 | Securacath Universal | Interrad Medical, Inc. | 2010 | — |
| +2 | K120935 | Securacath | Interrad Medical, Inc. | 2012 | — |
| +3 | K180769 | SecurAcath | Interrad Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 KMK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
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?
- Of its descendants, K082047 (Interrad Medical, Inc., 2008) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KMK devicesKMK Device, Intravascular Catheter Securement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMK
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KMK
Too few KMK 510(k)s in any year since 2007 to give a median.
Recalls per year · KMK
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMK
75in 2025
MAUDE reports naming product code KMK, 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 | 0 | — | 3 | 1 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 2 | 19 |
| 2017 | 0 | — | 0 | 45 |
| 2018 | 0 | — | 0 | 40 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 103 |
| 2023 | 0 | — | 0 | 138 |
| 2024 | 0 | — | 0 | 104 |
| 2025 | 0 | — | 0 | 75 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K943147 · printed Nov 5, 2026
Cite this page
510(k) Report. “K943147: Statlock CV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943147
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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