# K080579: Effectiv (TM) Cap

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Sep 11, 2008 after 192 days
- Product code: QBP (Cap, Device Disinfectant)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K030467 (2003). 2 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063239: Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526, Hospira, Inc. (2006) Summary page 5.

## Cited in the summary but kept off the family tree
- K033182: Prizm Keratome Blade (B.D. Model), Model MK8530BD, Surgin Surgical Instrumentation, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K083508: Swabcap (2009), 23 descendants of its own
- K093229: Catheter Connections Dualcap (2010), 8 descendants of its own
- K111992: Curos Port Protector (2012), 6 descendants of its own
- K112791: Sitescrub Ipa Device (2012), 3 descendants of its own
- K130975: Swabcap and Swabflush (2013), 2 descendants of its own

## Indications for use
The Effectiv™ Cap is a device containing 70% Isopropyl alcohol. When left in place for 5 to 10 minutes the cap decontaminates the injection port; thereafter the cap provides a physical barrier during intended use.

Source page: https://510kreport.com/device/K080579
Methodology: https://510kreport.com/methodology