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Lopez Lock

by ICU Medical, Inc.

510(k) K840273

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 NumberK840273 Date6 Mar 1984ClearedStatusActive

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  • Withdrawn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, 26 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 Lopez Lock is a closed enteral tube valve designed to provide access to enteral systems without opening lines. It minimizes risk to patients and protects healthcare workers from exposure to gastric fluids and bloodborne pathogens.

The device is supplied by ICU Medical, Inc. and was granted FDA 510(k) clearance under K840273 on March 6, 1984, as substantially equivalent to a predicate device. It is intended for use in general hospital settings and is identified by the product code FPA.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Questions

AI-generated answers, 26 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 is the Lopez Lock used for?

    The Lopez Lock is a closed enteral tube valve designed to provide access to enteral systems without opening lines. It minimizes risk to patients and protects healthcare workers from exposure to gastric fluids and bloodborne pathogens by maintaining a sealed system during access.

  • How is the Lopez Lock supplied and is it single-use or reusable?

    The Lopez Lock is supplied by ICU Medical, Inc. as a device intended for use in general hospital settings. While the data does not explicitly state whether it is single-use or reusable, its design as a closed valve for accessing enteral systems without opening lines suggests it is intended for repeated use within a closed system, consistent with its function to protect workers from exposure.

  • What regulatory clearance does the Lopez Lock have and under what number?

    The Lopez Lock was granted FDA 510(k) clearance under K840273 on March 6, 1984, as substantially equivalent to a predicate device. This clearance confirms its substantial equivalence to a legally marketed device for the same intended use.