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Nebulizer Bacteria Filter MC-350

by Medicomp, Inc.

Nebulizer Bacteria Filter MC-350 is a Class II device made by Medicomp, Inc., cleared under FDA 510(k) K851070 on 14 Jun 1985 and listed in FDA GUDID since 11 Sep 2017 (UDI-DI 00858409005023), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K851070

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858409005023 UDI-DI Date11 Sep 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK851070 Date14 Jun 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K851070 decided 14 Jun 1985 Active
  • FDA GUDID UDI-DI 00858409005023 listed 11 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K851070
  2. Listed FDA GUDID 00858409005023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nebulizer Bacteria Filter
Generic name
Straight/elbow breathing circuit connector, single-use
Model / Ref / Catalog
MC-350
Primary DI / UDI-DI
00858409005023
510(k) Number
FDA product code
CAH
GMDN term
Straight/elbow breathing circuit connector, single-use
Device class
Class II
Regulation number
868.5260
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K851070)

Similar devices

Other devices filed under FDA product code CAH (Filter, Bacterial, Breathing-Circuit).

Other devices from Medicomp, Inc.

See all devices from Medicomp, Inc. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)