# K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro

- Pathway: 510(k) (Traditional)
- Applicant: Carmel Pharma Ab.
- Decided: Mar 3, 1998 after 29 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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 K883614 (1988). 4 ancestors in all.
49 later devices descend from it; 7 cite it directly.
3 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972527: Phaseal, System for Sealed Handling of Chemotherapeutic Agents, Quality System Consulting (1997) Summary page 1.
- (no number) Codan Medlon, IV Administration Set - Catalog Rev 3/1/93 B&P: named in the summary without a submission number
- (no number) Codan Medlon Inc. Vented Set (C 302 and C430): named in the summary without a submission number
- (no number) Carmel Pharma ab, Infusion Set: named in the summary without a submission number
- (no number) Codan Medlon Inc. (BC 103) Special Accessories Luer Lock Plug: named in the summary without a submission number
- (no number) Carmel Pharma ab Connector: named in the summary without a submission number
- (no number) Codan Medloc Inc. Vented Set (BC 589): named in the summary without a submission number

## Most influential descendants
- K023747: Phaseal (2002), 38 descendants of its own
- K110023: Infusion Adapter C100 (2011), 37 descendants of its own
- K060866: Phaseal - Closed System for the Preparation and Administration of Parenteral Drugs (2006), 36 descendants of its own
- K120384: Protector, Injector, Connector (2012), 35 descendants of its own
- K123213: BD Phaseal Closed System Transfer Device (2013), 34 descendants of its own

## Indications for use
PhaSeal Infusion Adapter - Intravascular Administration Set The Infusion Adapter serves as the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique. PhaSeal Protection Cap — Special accessories The Protection Cap is intended to be used as a mechanical cover for the membrane in the bayonet fitting of PhaSeal devices The Protection Cap mates with the other PhaSeal components equipped with the bayonet fitting. One end of the Protection Cap has a male bayonet fitting and in the other a female bayonet fitting. PhaSeal Secondary Set — Intravascular Administration Set The Secondary Set is a non-vented infusion set used when drug is-handled as an admixtute and is administered via Intravenous infusion. The Secondary Set has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal technique. PhaSeal Extension Set - Intravascular Administration Set The Extension Set serves as the port for bolus injection with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Extension Set has a built in Connector which makes it possible inject drugs into the IV line of the patient using the sealed double membrane technique.

Source page: https://510kreport.com/device/K980381
Methodology: https://510kreport.com/methodology