# K964918: Nima Needleless Injectionsite Master Adapter with Posiflow Positive Displacement Feature, and I.V. Sets

- Pathway: 510(k) (Traditional)
- Applicant: Critical Device Corp.
- Decided: Apr 14, 1997 after 126 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NIMA™ Needleless Injectionsite Master Adapter with PosiFlow™ Positive Displacement Feature, and IV Sets: named in the summary without a submission number

## Recalls of this device
- Sep 9, 2010 · Not classified · Z-0155-2011: During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties o
- Sep 9, 2010 · Not classified · Z-0154-2011: During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties o
- Sep 9, 2010 · Not classified · Z-0156-2011: During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties o
- Sep 9, 2010 · Not classified · Z-0157-2011: During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties o
- Mar 3, 2005 · Not classified · Z-0853-05: Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
- Mar 3, 2005 · Not classified · Z-0854-05: Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
- Jan 20, 2005 · Not classified · Z-0693-05: Product older than three years may not operate as intended.
- Jan 20, 2005 · Not classified · Z-0694-05: Product older than three years may not operate as intended.

## Indications for use
For use as a needleless alternative to IV set injection ports. The NIMA™ adapter will replace the conventional Y-site on a primary IV line as a continuous or intermittent connection. For use as part of a program to reduce needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV. For use as a replacement to the injection cap (heparin cap) on an I.V. catheter for intermittent injections. For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids. For use with standard luer taper connections. For single patient use.

Source page: https://510kreport.com/device/K964918
Methodology: https://510kreport.com/methodology