# K972527: Phaseal, System for Sealed Handling of Chemotherapeutic Agents

- Pathway: 510(k) (Traditional)
- Applicant: Quality System Consulting
- Decided: Sep 18, 1997 after 73 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
Longest line of descent: 1 generation back to K883614 (1988). 3 ancestors in all.
56 later devices descend from it; 5 cite it directly.
3 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883614: Cytoguard (R), Survival Technology, Inc. (1988) Summary page 1.
- K951254: Safetyglide Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 1.
- K940961: Monoject Luer Adapter, Sherwood Medical Co. (1994) Summary page 1.
- (no number) Codan Medlon, IV Administration Set — Catalog #443: named in the summary without a submission number

## Most influential descendants
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro (1998), 49 descendants of its own
- K023747: Phaseal (2002), 38 descendants of its own
- K110023: Infusion Adapter C100 (2011), 37 descendants of its own
- K092782: Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35, (2009), 36 descendants of its own
- K060866: Phaseal - Closed System for the Preparation and Administration of Parenteral Drugs (2006), 36 descendants of its own

## Indications for use
PhaSeal Protector 20 - Drug Vial Transfer Adapter The Protector 20 is fitted to the drug vial and is used as a docking station between the drug vial for the parenteral drug and Injector Luer. In addition the Protector 20 equilibrates the pressure difference which occurs when fluid or air is added or removed from the drug vial. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that can occur during the reconstitution, administration and disposal processes. PhaSeal Injector Luer — Drug Transfer Needle Device The Injector Luer has an encapsulated cannula that is permanently locked onto a syringe using a Luer fitting. Sealed transfer of diluent, drug or air, between the single-use syringe and the various components in the system can be made via the Injector Luer in both the preparation and administration phases. PhaSeal Connector Luer-Lock — Luer Lock Device The Connector Luer Lock ensures a sealed connection between the single-use syringe and Injector Luer and the patient’s IV line. With the help of the Connector Luer Lock, injections can be made without drug spillage. PhaSeal Infusion Set - Intravascular Administration Set The Infusion Set is a non-vented infusion device that has a built-in connector to be used as a way of making additions of parenteral drugs to infusion fluids in a closed system. The Infusion Set may be used to administer the infusion fluid.

Source page: https://510kreport.com/device/K972527
Methodology: https://510kreport.com/methodology