Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IrelandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Aerogen and its 1 subsidiaries with 13 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated Sep 2, 2025: Aerogen Pro-X1 Controller System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Aerogen and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 2, 2025 | Aerogen Pro-X1 Controller SystemK251615 · SFP | 510(k) clearances |
| May 10, 2024 | Aerogen®Solo Nebulizer SystemK232507 · CAF | 510(k) clearances |
| Jul 10, 2015 | Aeroneb USB Contoller SystemK143719 · CAF | 510(k) clearances |
| Oct 17, 2014 | AERONEB SOLO; AERONEB SOLO ADAPTERK133360 · CAF | 510(k) clearances |
| Sep 2, 2014 | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-preClass II · Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and u | Device recalls |
| Sep 2, 2014 | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-preClass II · Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and u | Device recalls |
| Sep 2, 2014 | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-preClass II · Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and u | Device recalls |
| Sep 2, 2014 | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-preClass II · Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and u | Device recalls |
| Apr 26, 2012 | AERONEB PROK120939 · CAF | 510(k) clearances |
| May 13, 2011 | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) SK103635 · CAF | 510(k) clearances |
| Nov 10, 2010 | NIVO NEBULIZER SYSTEMK102240 · CAF | 510(k) clearances |
| Oct 23, 2008 | AERONEB GO NEBULIZERK081650 · CAF | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
