# K063239: Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Dec 11, 2006 after 46 days
- Product code: FPK (Tubing, Fluid Delivery)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030467 (2003). 1 ancestor in all.
56 later devices descend from it; 2 cite it directly.
5 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030467: Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set, Iv Medical, Inc. (2003) Summary page 2.
- (no number) LifeShield® Latex-Free Regulator I.V. Dial-A-Flo® set family: named in the summary without a submission number

## Most influential descendants
- K101677: Hospira Infusion Blood Sets (2010), 30 descendants of its own
- K080579: Effectiv (TM) Cap (2008), 24 descendants of its own
- K083508: Swabcap (2009), 23 descendants of its own
- K113683: Lifeshield Vision Infusion Set with Pre-Pierced Reseal (2012), 19 descendants of its own
- K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade (2015), 9 descendants of its own

## Recalls of this device
- Nov 24, 2009 · Not classified · Z-1330-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1390-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1333-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1336-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1331-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1391-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1327-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

## Indications for use
The LifeShield® Latex-Free GraviTechTM Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTechTM Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.

Source page: https://510kreport.com/device/K063239
Methodology: https://510kreport.com/methodology