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pNeuton mini neo

by Airon Corporation

pNeuton mini neo (20041) is a Class II device made by Airon Corporation, cleared under FDA 510(k) K121379 on 11 Oct 2012 and listed in FDA GUDID since 11 Oct 2019 (UDI-DI 00853678006719), active as of 22 Oct 2026.

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

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) K121379

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 Number00853678006719 UDI-DI Date11 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121379 Date11 Oct 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121379 decided 11 Oct 2012 Active
  • FDA GUDID UDI-DI 00853678006719 listed 11 Oct 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121379
  2. Listed FDA GUDID 00853678006719

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
pNeuton
Generic name
Portable pneumatic ventilator
Model / Ref / Catalog
mini neo, 20041
Primary DI / UDI-DI
00853678006719
510(k) Number
FDA product code
CBK
GMDN term
Portable pneumatic ventilator
Device class
Class II
Regulation number
868.5895
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Height — 6.0 Inch
Width — 8.7 Inch
Depth — 7.8 Inch
Weight — 9 Pound

Related devices

Category: Portable pneumatic ventilator

Cleared under the same submission (K121379)

and 8 more cleared under K121379

Similar devices

Other devices filed under FDA product code CBK (Ventilator, Continuous, Facility Use).

Other devices from Airon Corporation

See all devices from Airon Corporation →

Properties

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