# K994216: Plastic Port Implantable Venous Access System

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Jan 27, 2000 after 43 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 11 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830730 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830730: Port-a-Cath Implantable Cath. Sys, Pharmacia, Inc. (1983) Summary page 2.
- K875276: Port-a-Cath (R) Implantable Drug Delivery System, Pharmacia Deltec, Inc. (1988) Summary page 2.
- K932840: Port-a-Cath Implantable Vascular Access System, Pharmacia Deltec, Inc. (1994) Summary page 2.
- K942024: Port-a-Cath Low Profile Implantable Venous Access System, Pharmacia Deltec, Inc. (1994) Summary page 2.
- (no number) M.R.L® Implanted Ports: named in the summary without a submission number

## Recalls of this device
- Feb 13, 2025 · Class I · Z-1287-2025: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Feb 13, 2025 · Class I · Z-1281-2025: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Feb 13, 2025 · Class I · Z-1282-2025: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Feb 13, 2025 · Class I · Z-1280-2025: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Feb 13, 2025 · Class I · Z-1283-2025: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Feb 13, 2025 · Class I · Z-1288-2025: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Mar 29, 2004 · Not classified · Z-0874-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri
- Mar 29, 2004 · Not classified · Z-0871-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri
- Mar 29, 2004 · Not classified · Z-0875-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri
- Mar 29, 2004 · Not classified · Z-0872-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri
- Mar 29, 2004 · Not classified · Z-0873-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri

## Indications for use
A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Source page: https://510kreport.com/device/K994216
Methodology: https://510kreport.com/methodology