# K082047: Securacath Catheter, Model SPK01

- Pathway: 510(k) (Traditional)
- Applicant: Interrad Medical, Inc.
- Decided: Sep 30, 2008 after 74 days
- Product code: OKC (Implanted Subcutaneous Securement Catheter)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 15 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060887: Angiodynamic, Inc. Morpheus CT Picc and Procedure Kit, AngioDynamics, Inc. (2006) Summary page 2.
- K041849: Turbo-Flo Picc, Cook, Inc. (2005) Summary page 2.
- K053501: Powerpicc, Bard Access Systems, Inc. (2006) Summary page 2.
- K943147: Statlock CV, Venetec, Inc. (1994) Summary page 2.

## Cited in the summary but kept off the family tree
- K000190: Modification to Carto EP Navigation System, Biosense Webster, Inc. (2000). Our reading of the summary gave K000190, FDA’s number for Modification to Carto EP Navigation System (Biosense Webster, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Poly-Per-Q”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K083081: Modification to Securacath, Model: SPK01 (2009), 5 descendants of its own
- K092306: Securacath Universal (2010), 4 descendants of its own
- K120935: Securacath (2012), 3 descendants of its own
- K180769: SecurAcath (2018), 2 descendants of its own
- K180994: SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F (2019), 1 descendant of its own

## Indications for use
The SecurAcath is a PICC and is indicated for short and long term use in peripheral vessels to access the central venous system. The catheter may be used for blood sampling and/or infusion therapy. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.

Source page: https://510kreport.com/device/K082047
Methodology: https://510kreport.com/methodology