510(k) Report

FDA applicant

Monaghan Medical Corp.

Plattsburgh, NY35 decisions1976–20230 recalls

FDA records 35 decisions for Monaghan Medical Corp. (Plattsburgh, NY) from 1976 to 2023: 35 510(k) clearances. Most are in product codes BZH (Meter, Peak Flow, Spirometry) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 12 predicates, 10 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Monaghan Medical Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Monaghan Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2011: 12013: 12023: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Monaghan Medical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Monaghan Medical Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • BZHMeter, Peak Flow, Spirometry10decisions
  • CAFNebulizer (Direct Patient Interface)5decisions
  • BYPMouthpiece, Breathing3decisions
  • FFKLithotriptor, Electro-Hydraulic3decisions
  • CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)3decisions
  • BWFSpirometer, Therapeutic (Incentive)2decisions

Also: CBK (2), BZQ (2), CAI (1), CAZ (1), BZK (1), BZA (1).

Whose devices does it build on?

Its devices cite 12 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K872037AerochamberMonaghan Medical Corp. · 19874cite it
  • K926307Peak Flow MeterMonaghan Medical Corp. · 19934cite it
  • K955234Trupeak Peak Flow MeterMonaghan Medical Corp. · 19962cite it
  • K963095Trupeak Peak Flow MeterMonaghan Medical Corp. · 19961cites it
  • K900557Modified Aerochamber M.V. Aerosol Holding ChamberMonaghan Medical Corp. · 19911cites it
  • K894969AeroventMonaghan Medical Corp. · 19891cites it

What has FDA decided for it lately?

  • K220145Monaghan medical filtered mouthpiece kitMonaghan Medical Corporation · 2023
  • K123945Strive Dual Zone Peak Flow MeterMonaghan Medical Corp. · 2013
  • K110273Aerovent Plus CHCMonaghan Medical Corporation · 2011
  • K031514Modification to Trupeak Peak Flow MeterMonaghan Medical Corp. · 2003
  • K023097Truezone Peak Flow MeterMonaghan Medical Corp. · 2003
  • K012939Aerovent II CHC Collapsible Holding ChamberMonaghan Medical Corp. · 2001
  • K991212Modification to Truzone Peak Flow MeterMonaghan Medical Corp. · 1999
  • K964130Aerogear Asthma Action KitMonaghan Medical Corp. · 1997

All 33 as Monaghan Medical Corp. →All 2 as Monaghan Medical Corporation →