510(k) Report

FDA applicant

Rocap Div. of Sabratek Corp.

Orlando, FL3 decisions1999–19990 recalls

FDA records 3 decisions for Rocap Div. of Sabratek Corp. (Orlando, FL) in 1999: 3 510(k) clearances. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). 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 Rocap Div. of Sabratek Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rocap Div. of Sabratek Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rocap Div. of Sabratek Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days3decisions

What has FDA decided for it lately?

  • K990390Heparin IV Flush Syringe, 10 U/ML \Rocap Div. of Sabratek Corp. · 1999
  • K990308Rocap Heparin IV Flush Syringe, 100U/MLRocap Div. of Sabratek Corp. · 1999
  • K984614Normal Saline Flush SyringeRocap Div. of Sabratek Corp. · 1999

All 3 as Rocap Div. of Sabratek Corp. →