510(k) Report

FDA applicant

Puracath Medical, Inc.

Newark, CA3 decisions2016–20260 recalls

FDA records 3 decisions for Puracath Medical, Inc. (Newark, CA) from 2016 to 2026: 3 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and KDJ (Set, Administration, For Peritoneal Dialysis…). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is 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 Puracath Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2016: 12021: 12026 (partial year): 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Puracath Medical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular2decisions
  • KDJSet, Administration, For Peritoneal Dialysis, Disposable1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203796Firefly Needleless ConnectorPuracath Medical, Inc. · 20211cites it

What has FDA decided for it lately?

  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026
  • K203796Firefly Needleless ConnectorPuracath Medical, Inc. · 2021
  • K151620Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc. · 2016

All 3 as Puracath Medical, Inc. →