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Lockbox

by Pharmacia Deltec, Inc. 2 variants

510(k) K942161

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)ST Traditional NumberK942161 Date2 Aug 1994DecidedStatusActive

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  • Withdrawn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
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
ST

Overview

AI-generated summary, 27 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 Lockbox is an infusion pump device. It is designed to function as a component within infusion systems.

This device is authorized under FDA 510(k) clearance. It is classified as a Class II medical device.

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Questions

AI-generated answers, 27 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 primary function of the Lockbox?

    The Lockbox is designed to serve as a component within infusion systems, supporting the operation of infusion pump equipment.

  • What is the regulatory classification of this device?

    The Lockbox is classified as a Class II medical device and is authorized under FDA 510(k) clearance, which indicates it has been found substantially equivalent to a legally marketed predicate device.

  • Which medical specialty is this device associated with?

    The device is categorized under the General Hospital advisory committee, reflecting its intended use within standard clinical infusion environments.