# K083081: Modification to Securacath, Model: SPK01

- Pathway: 510(k) (Traditional)
- Applicant: Interrad Medical, Inc.
- Decided: Mar 4, 2009 after 139 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: 8 generations back to K001901 (2000). 16 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K082047: Securacath Catheter, Model SPK01, Interrad Medical, Inc. (2008) Summary page 2.
- K051672: Powerpicc, Bard Access Systems, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K210629: SecurAcath (2021), 0 descendants of its own

## Indications for use
The SecurAcath PICC is indicated for short or long term peripheral access to the central venous system. The catheter may be used for intravenous therapy, power injection of contrast media, and blood sampling and/or infusion therapy... The maximum recommended infusion rate is 5 ml/sec and the maximum pressure of power injectors may not exceed 300 psi. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.

Source page: https://510kreport.com/device/K083081
Methodology: https://510kreport.com/methodology