510(k) Report

FDA applicant

P/L Biomedical

Fort Myers, FL3 decisions1997–201216 recalls

FDA records 3 decisions for P/L Biomedical (Fort Myers, FL) from 1997 to 2012: 3 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FPA (Set, Administration, Intravascular). Its devices cite 2 predicates, 0 of them its own earlier devices. 16 recalls are linked to its devices.

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 P/L Biomedical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

16in 2014

2014: 16
2007high 16 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — P/L Biomedical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like P/L Biomedical’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?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 0 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.

  • K972135Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 19978cite it
  • K122969Clickfine Pen NeedleP/L Biomedical · 20121cites it
  • K122971Clickfine Pen NeedleP/L Biomedical · 20121cites it

What has FDA decided for it lately?

  • K122969Clickfine Pen NeedleP/L Biomedical · 2012
  • K122971Clickfine Pen NeedleP/L Biomedical · 2012
  • K972135Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 199716 recalls

All 3 as P/L Biomedical →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K972135ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or…Nov 20, 2014Class II
  • K972135ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or…Nov 20, 2014Class II
  • K972135ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or…Nov 20, 2014Class II
  • K972135ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or…Nov 20, 2014Class II
  • K972135ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion…Nov 20, 2014Class II
  • K972135ACCU-CHEK Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion…Nov 20, 2014Class II