# K021557: Spectrum Silicone Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: May 30, 2003 after 382 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K862056 (1986). 7 ancestors in all.
126 later devices descend from it; 4 cite it directly.
17 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992198: Urethane Picc Line Model Upics-, Cook, Inc. (1999) Summary page 2.
- K010034: Double Lumen Urethane Picc Line, Model Upicds-, Cook, Inc. (2001)
- K950118: Abrm Catheter, Cook, Inc. (1996) Summary page 2.
- K011812: Spectrum Ventricular Catheter, Cook, Inc. (2001)
- K000251: Spectrum Silicone Foley Catheter, Cook Urological, Inc. (2000)
- K993691: Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (2000) Summary page 2.

## Cited in the summary but kept off the family tree
- K013605: Silicone Catheter. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line (2005), 119 descendants of its own
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter (2007), 66 descendants of its own
- K061179: Powerhickman Long-Term Intravascular Catheter (2006), 47 descendants of its own
- K091953: Pro-Picc (2009), 29 descendants of its own
- K101326: NMI IC (2010), 26 descendants of its own

## Indications for use
The COOK Spectrum®Silicone Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. Catheters are available in single and double lumen PICC; and single, double and triple lumen CVC. The device is supplied sterile and intended for one-time use.

Source page: https://510kreport.com/device/K021557
Methodology: https://510kreport.com/methodology