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MaxFlo2 R223P01-005

by Maxtec, Inc.

MaxFlo2 R223P01-005 is a Class II device made by Maxtec, Inc., cleared under FDA 510(k) K113232 on 1 Mar 2012 and listed in FDA GUDID since 14 Jan 2019 (UDI-DI 00853061006135), 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) K113232

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 Number00853061006135 UDI-DI Date14 Jan 2019ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113232 Date1 Mar 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113232 decided 1 Mar 2012 Active
  • FDA GUDID UDI-DI 00853061006135 listed 14 Jan 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113232
  2. Listed FDA GUDID 00853061006135

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MaxFlo2
Generic name
Oxygen/air breathing gas mixer, hospital
Model / reference
R223P01-005
Primary DI / UDI-DI
00853061006135
510(k) Number
FDA product code
BZR
GMDN term
Oxygen/air breathing gas mixer, hospital
Device class
Class II
Regulation number
868.5330
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K113232)

Similar devices

Other devices filed under FDA product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation).

Other devices from Maxtec, Inc.

See all devices from Maxtec, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)