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pNeuton 58210

by Airon Corporation

pNeuton 58210 is a Class II device made by Airon Corporation, cleared under FDA 510(k) K925217 on 26 Jan 1993 and listed in FDA GUDID since 10 Jan 2017 (UDI-DI 00853678006672), active as of 22 Oct 2026. 2 FDA recalls are 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

2 ongoing

This device is named in the recall

Documents

510(k) K925217

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 Number00853678006672 UDI-DI Date10 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK925217 Date26 Jan 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K925217 decided 26 Jan 1993 Active
  • FDA GUDID UDI-DI 00853678006672 listed 10 Jan 2017 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0449-2026 FDA Class I initiated 10 Oct 2025

    Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

    • Ongoing Z-3031-2024 FDA Class II initiated 8 Apr 2024

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Timeline

4 dated events

  1. Cleared FDA 510(k) K925217
  2. Listed FDA GUDID 00853678006672
  3. Recall initiated FDA recalls Z-3031-2024
  4. Recall initiated FDA recalls Z-0449-2026

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  • Withdrawn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
Non-respiratory device ambient air filter
Model / Ref / Catalog
58210
Primary DI / UDI-DI
00853678006672
510(k) Number
FDA product code
CAH
GMDN term
Non-respiratory device ambient air filter
Device class
Class II
Regulation number
868.5260
GUDID distribution status
In Commercial Distribution
Size
Weight — 0.04 Pound
Height — 2.50 Inch
Width — 2.50 Inch
Length — 2.75 Inch

Related devices

Category: Non-respiratory device ambient air filter

Cleared under the same submission (K925217)

and 8 more cleared under K925217

Similar devices

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

Other devices from Airon Corporation

See all devices from Airon Corporation →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)