# K030467: Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Iv Medical, Inc.
- Decided: Mar 14, 2003 after 30 days
- Product code: FPA (Set, Administration, Intravascular)
- 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
No predicates in its family tree.
57 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063239: Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526 (2006), 56 descendants of its own
- 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

## Indications for use
GraviTechm is a single use, disposable gravitydriven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body- GraviTechm Primary Sets are for use in cdntrolling the infusion rate of I.V. fluids from the solution bag to a patient catheter, which is inserted into a human vein. GraviTech” Extension Sets are intended for use in conjunction with commonly used 1.V primary sets for conhlling the infusion mte of I.V. fluids into the human body. Note: The use of any Needleless connector may aid in the prevention of needle stick injuries.

Source page: https://510kreport.com/device/K030467
Methodology: https://510kreport.com/methodology