Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Monaghan Medical Corp. — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
354 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123945 | STRIVE DUAL ZONE PEAK FLOW METER | Monaghan Medical Corp. | 2013-04-17 | 117 | 0 |
| K031514 | MODIFICATION TO TRUPEAK PEAK FLOW METER | Monaghan Medical Corp. | 2003-05-23 | 9 | 0 |
| K023097 | TRUEZONE PEAK FLOW METER | Monaghan Medical Corp. | 2003-03-07 | 170 | 0 |
| K012939 | AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER | Monaghan Medical Corp. | 2001-09-28 | 28 | 0 |
| K991212 | MODIFICATION TO TRUZONE PEAK FLOW METER | Monaghan Medical Corp. | 1999-07-01 | 83 | 0 |
| K964130 | AEROGEAR ASTHMA ACTION KIT | Monaghan Medical Corp. | 1997-01-10 | 87 | 0 |
| K963089 | TRUZONE PEAK FLOW METER | Monaghan Medical Corp. | 1996-11-06 | 90 | 0 |
| K963095 | TRUPEAK PEAK FLOW METER | Monaghan Medical Corp. | 1996-11-04 | 88 | 0 |
| K955234 | TRUPEAK PEAK FLOW METER | Monaghan Medical Corp. | 1996-03-18 | 125 | 0 |
| K955262 | TRUZONE PEAK FLOW METER | Monaghan Medical Corp. | 1996-03-07 | 114 | 0 |
| K944512 | TRUZONE PFM DISPOSABLE MOUTHPIECE | Monaghan Medical Corp. | 1994-11-02 | 48 | 0 |
| K930574 | AEROCHAMBER W/MASK, MODIFIED | Monaghan Medical Corp. | 1994-01-24 | 354 | 0 |
| K926307 | PEAK FLOW METER | Monaghan Medical Corp. | 1993-07-22 | 219 | 0 |
| K911263 | 22MM ID/OD ADAPTER | Monaghan Medical Corp. | 1991-08-19 | 150 | 0 |
| K900576 | MODIFIED AEROCHAMBER WITH MASK | Monaghan Medical Corp. | 1991-05-13 | 460 | 0 |
| K900557 | MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER | Monaghan Medical Corp. | 1991-04-10 | 427 | 0 |
| K910138 | TVS II ELECTRONIC INCENTIVE SPIROMETER | Monaghan Medical Corp. | 1991-03-12 | 57 | 0 |
| K884389 | MODIFIED 225/SIMV VOLUME VENTILATOR | Monaghan Medical Corp. | 1990-03-12 | 510 | 0 |
| K894969 | AEROVENT | Monaghan Medical Corp. | 1989-10-30 | 84 | 0 |
| K884942 | MONAGHAN RVM, MODEL 761 | Monaghan Medical Corp. | 1989-06-07 | 194 | 0 |
| K884803 | AEROCHAMBER M.V. | Monaghan Medical Corp. | 1989-04-26 | 160 | 0 |
| K874513 | MONAGHAN AEROCHAMBER WITH MASK | Monaghan Medical Corp. | 1987-12-30 | 58 | 0 |
| K872037 | AEROCHAMBER | Monaghan Medical Corp. | 1987-07-24 | 58 | 0 |
| K863612 | MONAGHAN RVM, MODEL 760 AND 761 | Monaghan Medical Corp. | 1986-10-15 | 29 | 0 |
| K853047 | MONAGHAN RVM, MODEL 760 OR MODEL 761 | Monaghan Medical Corp. | 1985-11-18 | 122 | 0 |
| K834228 | LITHOTRIPTOR ELECTRODE 4.5F | Monaghan Medical Corp. | 1984-05-25 | 171 | 0 |
| K830086 | 4.5 F LITHOTRIPTOR ELECTRODE | Monaghan Medical Corp. | 1983-02-09 | 29 | 0 |
| K822635 | 225 S.I.M.V. VENTILATOR | Monaghan Medical Corp. | 1982-11-16 | 77 | 0 |
| K822437 | MONAGHAN AEROCHAMBER | Monaghan Medical Corp. | 1982-11-03 | 82 | 0 |
| K822585 | LITHOTRIPTOR ELECTRODE 4.5F | Monaghan Medical Corp. | 1982-09-28 | 33 | 0 |
| K821649 | MONAGHAN'S PRESSURE ALARM | Monaghan Medical Corp. | 1982-08-05 | 62 | 0 |
| K820606 | MONAGHAN'S TRUE VOLUME EXERCISER | Monaghan Medical Corp. | 1982-03-23 | 18 | 0 |
| K760352 | CIRCUIT, INTENSIVE CARE VENTILATOR | Monaghan Medical Corp. | 1976-08-11 | 9 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda