510(k) · Cleared
ClearedSecuracath Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interrad Medical, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jul 9, 2010 as substantially equivalent to K082047 (Interrad Medical, Inc., 2008) and 2 other predicates after a 345-day review. Its family tree reaches back 9 generations to 2000. 1 of the 22 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Jul 9, 2010
- Review
- 345 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K001901 (2000). 17 ancestors in all, the oldest K862056 (1986). 4 later devices descend from it, 1 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK053501 PowerpiccBard Access Systems, Inc. · 2006
- 2 generations backK082047 Securacath Catheter, Model SPK01Interrad Medical, Inc. · 2008
- 1 generation backK083081 Modification to Securacath, Model: SPK01Interrad Medical, Inc. · 2009
- This deviceK092306 Securacath UniversalInterrad Medical, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK120935 SecuracathInterrad Medical, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK180769 SecurAcathInterrad Medical, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK180994 SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F…Interrad Medical, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK210629 SecurAcathInterrad Medical, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 4 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 3 generations backK053501 PowerpiccBard Access Systems, Inc. · 2006
- 2 generations backK082047 Securacath Catheter, Model SPK01Interrad Medical, Inc. · 2008
- 1 generation backK083081 Modification to Securacath, Model: SPK01Interrad Medical, Inc. · 2009
- This deviceK092306 Securacath UniversalInterrad Medical, Inc. · 2010
Class I recalls in this family
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip4 generations back · 1986
Most influential descendants
Showing 4 of 4 · See all- K120935SecuracathInterrad Medical, Inc. · 2012 · cites it directly3descendants
- K180769SecurAcathInterrad Medical, Inc. · 2018 · 2 generations on2descendants
- K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…Interrad Medical, Inc. · 2019 · 3 generations on1descendant
- K210629SecurAcathInterrad Medical, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −4 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −3 | K053501 | Powerpicc | Bard Access Systems, Inc. | 2006 | — |
| −2 | K082047 | Securacath Catheter, Model SPK01 | Interrad Medical, Inc. | 2008 | — |
| −1 | K083081 | Modification to Securacath, Model: SPK01 | Interrad Medical, Inc. | 2009 | — |
| 0 (this device) | K092306 | Securacath Universal | Interrad Medical, Inc. | 2010 | — |
| +1 | K120935 | Securacath | Interrad Medical, Inc. | 2012 | — |
| +2 | K180769 | SecurAcath | Interrad Medical, Inc. | 2018 | — |
| +3 | K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F… | Interrad Medical, Inc. | 2019 | — |
| +4 | K210629 | SecurAcath | Interrad Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 1 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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.
1 device in this family has a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K082047 | Securacath Catheter, Model SPK01Summary page 1…Classification Name Accessory to a percutaneous, implanted, long-term intravascular catheter Predicate Devices Interrad SecurAcath Catheter (K082047, K08308 1) Venetec Statlock (K943 147, now 5 10(k) exempt) Arrow Staple Anchoring Device, which is pr… | 2008 |
| * | K083081 | Modification to Securacath, Model: SPK01Summary page 1…ation Name Accessory to a percutaneous, implanted, long-term intravascular catheter Predicate Devices Interrad SecurAcath Catheter (K082047, K08308 1) Venetec Statlock (K943 147, now 5 10(k) exempt) Arrow Staple Anchoring Device, which is provided wit… | 2009 |
| * | K943147 | Statlock CVSummary page 1…rcutaneous, implanted, long-term intravascular catheter Predicate Devices Interrad SecurAcath Catheter (K082047, K08308 1) Venetec Statlock (K943 147, now 5 10(k) exempt) Arrow Staple Anchoring Device, which is provided with the Teleflex /Arrow Central… | 1994 |
| * | — | Arrow Staple Anchoring Device Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120935 | Securacath | 2012 | 3 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 4 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 5 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K120935 (Interrad Medical, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K082047.
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. 2010, 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 SecurAcath Universal Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092306 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092306: Securacath Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092306
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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