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Safecath

by Phase Medical Systems, Inc.

510(k) K880260

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880260 Date19 Apr 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SafeCath is a Disposable Central Venous Catheter Kit, designed for temporary or intermittent venous access in clinical settings. It facilitates the insertion of a central venous catheter to administer fluids, medications, or monitor central venous pressure, reducing infection risk through single-use design and sterile packaging.

This device is supplied sterile and intended for single-use in hospital or critical care environments. It complies with FDA 510(k) clearance (K880260) under product code FOZ, adhering to 21 CFR 880.5200 standards. No MRI safety or reusable specifications are noted; storage requires adherence to manufacturer guidelines for sterile, unopened kits.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical scenarios is the SafeCath designed for, and how does its single-use feature benefit patients?

    The SafeCath is designed for temporary or intermittent venous access in hospital or critical care settings, such as administering fluids, medications, or monitoring central venous pressure. Its single-use, sterile design significantly reduces infection risk by eliminating cross-contamination between patients, which is critical in high-risk environments like ICUs or post-operative care.

  • How should the SafeCath be stored before use, and what does the manufacturer recommend to maintain sterility?

    The SafeCath must be stored as a sterile, unopened kit following the manufacturer’s guidelines. It is not intended for reuse, so keeping the packaging intact until use ensures sterility. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these could compromise the sterile barrier.

  • Is the SafeCath compatible with MRI procedures, and what should clinicians consider regarding its use in imaging environments?

    The SafeCath does not have specified MRI safety information in its documentation, meaning its compatibility with MRI procedures is not confirmed. Clinicians should verify compatibility with their MRI facility’s protocols or consult the manufacturer before use in imaging environments to avoid potential risks.

  • What distinguishes the SafeCath’s regulatory pathway, and how does this affect its availability in clinical settings?

    The SafeCath follows the FDA’s 510(k) clearance pathway (K880260) under product code FOZ, classified as substantially equivalent to a predicate device. This means it has undergone FDA review for safety and effectiveness, ensuring it meets regulatory standards for temporary central venous access. Its clearance allows for distribution in U.S. clinical settings where central venous catheters are used.