510(k) Report

FDA applicant

Sims Deltec, Inc.

St. Paul, MN32 decisions1995–200162 recalls

FDA records 32 decisions for Sims Deltec, Inc. (St. Paul, MN) from 1995 to 2001: 32 510(k) clearances. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and FPA (Set, Administration, Intravascular). Its devices cite 18 predicates, 1 of them its own earlier devices. 62 recalls are linked to its devices, 6 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Sims Deltec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sims Deltec, Inc. since 2007.

Recalls per year

6in 2025

2007: 12009: 12011: 12013: 12017: 22025: 6, 6 Class I
2007high 6 (2025) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Sims Deltec, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sims Deltec, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular10decisions
  • FPASet, Administration, Intravascular9decisions
  • FRNPump, Infusion7decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • FPBFilter, Infusion Line1decision

Also: MEA (1).

Whose devices does it build on?

Its devices cite 18 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K982838Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400Sims Deltec, Inc. · 19984cite it
  • K960826Cadd-Prizm Model 6100 PumpSims Deltec, Inc. · 19962cite it
  • K000842Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemSims Deltec, Inc. · 20002cite it
  • K992697Port-a-Cath II Trans-Arterial Percutaneous SystemSims Deltec, Inc. · 19992cite it
  • K982839Cadd-Legacy Pca Ambulatory Infusion System, Model 6300Sims Deltec, Inc. · 19982cite it
  • K973917Cadd-Diplomat PC Communications System and the Cadd- Ambassador Pump Communications SystemSims Deltec, Inc. · 19981cites it

What has FDA decided for it lately?

  • K010426Proport Plastic Venous Implantable Access Systems Pre-Assembled with Silicone CatheterSims Deltec, Inc. · 2001
  • K000842Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemSims Deltec, Inc. · 20002 recalls
  • K000942Cadd Checkvalve Administration Set, Model 21-7090Sims Deltec, Inc. · 2000
  • K994216Plastic Port Implantable Venous Access SystemSims Deltec, Inc. · 20006 Class I recalls
  • K992697Port-a-Cath II Trans-Arterial Percutaneous SystemSims Deltec, Inc. · 1999
  • K992880P.a.S. Port Elite Implantable Venous Access SystemSims Deltec, Inc. · 19992 recalls
  • K991599Cadd Administration SetSims Deltec, Inc. · 199932 recalls
  • K991255Cadd-TPN Administration Set, Model 21-7071Sims Deltec, Inc. · 1999

All 32 as Sims Deltec, Inc. →

What has been recalled?

62 recalls linked to its devices; the latest:

  • K994216smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane…Feb 13, 2025Class I
  • K994216smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter…Feb 13, 2025Class I
  • K994216smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow…Feb 13, 2025Class I
  • K994216smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter…Feb 13, 2025Class I
  • K994216smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D.…Feb 13, 2025Class I
  • K994216smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter…Feb 13, 2025Class I

Other applicant names beginning “Sims”

FDA records each applicant name separately; these may or may not be the same firm.

Sims Portex, Inc. 16Sims Surgical, Inc. 3Sims Level 1, Inc. 2Sims 2