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Microstream DLPM35MN02

by Covidien LP

Microstream DLPM35MN02 is a Class II device made by Covidien LP, cleared under FDA 510(k) K200594 on 27 Apr 2020 (1 earlier submission) and listed in FDA GUDID since 28 May 2022 (UDI-DI 10884521786936), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521786936 UDI-DI Date28 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200594 Date27 Apr 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200594 decided 27 Apr 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521786936 listed 28 May 2022 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0515-2021 FDA Class II initiated 16 Nov 2020

    The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.

Timeline

4 dated events

  1. Cleared FDA 510(k) K150272
  2. Cleared FDA 510(k) K200594
  3. Recall initiated FDA recalls Z-0515-2021
  4. Listed FDA GUDID 10884521786936

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Microstream
Generic name
Carbon dioxide monitor
Model / reference
DLPM35MN02
Primary DI / UDI-DI
10884521786936
FDA product code
CCK
GMDN term
Carbon dioxide monitor
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Carbon dioxide monitor

Cleared under the same submission (K150272)

Cleared under the same submission (K200594)

Similar devices

Other devices filed under FDA product code CCK (ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE).

Other devices from Covidien LP

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  • Shiley 110870

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See all devices from Covidien LP →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)