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Primary & Secondary I.V. Tubing Sets

by David Simmonds Co., Inc.

510(k) K822848

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 NumberK822848 Date15 Oct 1982ClearedStatusActive

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

Primary & Secondary I.V. Tubing Sets are medical devices designed for the administration of intravenous fluids and medications. They consist of tubing sets that facilitate the delivery of fluids from a primary source and allow for the connection of a secondary line for additional infusions or medication administration.

These tubing sets are supplied non-sterile and are intended for single-use in general hospital settings. They are not MRI safe and should be stored according to manufacturer specifications. The device received FDA 510(k) clearance under K822848 with product code FPA, and is classified as substantially equivalent to a predicate device.

Other devices from David Simmonds Co., Inc.

Questions

AI-generated answers, 23 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 are Primary & Secondary I.V. Tubing Sets used for?

    These tubing sets are designed for the administration of intravenous fluids and medications, allowing delivery from a primary source and connection of a secondary line for additional infusions or medication administration in general hospital settings.

  • Are Primary & Secondary I.V. Tubing Sets sterile or non-sterile, and are they reusable?

    The device is supplied non-sterile and is intended for single-use only; it should not be reused due to the risk of contamination and lack of sterilization, as specified in the manufacturer's instructions.

  • What regulatory pathway was used for the Primary & Secondary I.V. Tubing Sets, and what is the associated clearance number?

    The device received FDA 510(k) clearance under K822848, indicating it was found substantially equivalent to a predicate device through the traditional 510(k) submission process.