Monaghan Medical Corp.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under 2 spellings of the applicant name “Monaghan Medical Corp.” (first 1976, latest 2023), across 13 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 117 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 582 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Monaghan Medical Corp. took a median 582 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 236 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | 10 | 10 |
| CAF | Nebulizer (Direct Patient Interface) | 5 | 5 |
| BYP | Mouthpiece, Breathing | 3 | 3 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 3 | 3 |
| FFK | Lithotriptor, Electro-Hydraulic | 3 | 3 |
| BWF | Spirometer, Therapeutic (Incentive) | 2 | 2 |
| BZQ | Monitor, Breathing Frequency | 2 | 2 |
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Monaghan Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220145 | Monaghan medical filtered mouthpiece kit | CAF | 2023-08-24 | 582 |
| K123945 | STRIVE DUAL ZONE PEAK FLOW METER | BZH | 2013-04-17 | 117 |
| K110273 | AEROVENT PLUS CHC | CAF | 2011-06-09 | 129 |
| K031514 | MODIFICATION TO TRUPEAK PEAK FLOW METER | BZH | 2003-05-23 | 9 |
| K023097 | TRUEZONE PEAK FLOW METER | BZH | 2003-03-07 | 170 |
| K012939 | AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER | CAF | 2001-09-28 | 28 |
| K991212 | MODIFICATION TO TRUZONE PEAK FLOW METER | BZH | 1999-07-01 | 83 |
| K964130 | AEROGEAR ASTHMA ACTION KIT | BZH | 1997-01-10 | 87 |
| K963089 | TRUZONE PEAK FLOW METER | BZH | 1996-11-06 | 90 |
| K963095 | TRUPEAK PEAK FLOW METER | BZH | 1996-11-04 | 88 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Monaghan Medical Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Monaghan Medical Corp. (a text match, not an official crosswalk):
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Monaghan Medical Corp. (33)
- Monaghan Medical Corporation (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Monaghan Medical Corp.?
FDA lists 35 510(k) clearances under 2 spellings of the applicant name “Monaghan Medical Corp.” (first 1976, latest 2023), across 13 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Monaghan Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Monaghan Medical Corp. is 88 days.
Which FDA product codes appear under Monaghan Medical Corp.?
The most frequent FDA product codes under this applicant name are BZH (Meter, Peak Flow, Spirometry, 10); CAF (Nebulizer (Direct Patient Interface), 5); BYP (Mouthpiece, Breathing, 3).
Next steps
- See all 35 Monaghan Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZH, Monaghan Medical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.