Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Newport Medical Instruments, Inc. · Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
408 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121891 | NEWPORT AURA VENTILATOR | Newport Medical Instruments, Inc. | 2012-11-09 | 133 | 0 |
| K111146 | NEWPORT HT70 VENTILATOR | Newport Medical Instruments, Inc. | 2011-12-01 | 223 | 4 |
| K101803 | NEWPORT E360 VENTILATOR | Newport Medical Instruments, Inc. | 2010-09-08 | 72 | 0 |
| K090888 | NEWPORT HT70 FAMILY OF VENTILATORS | Newport Medical Instruments, Inc. | 2009-11-18 | 232 | 4 |
| K082724 | NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM | Newport Medical Instruments, Inc. | 2008-12-16 | 90 | 2 |
| K061094 | NEWPORT E500 WAVE VENTILATOR | Newport Medical Instruments, Inc. | 2006-07-28 | 100 | 0 |
| K053502 | NEWPORT E360 VENTILATOR | Newport Medical Instruments, Inc. | 2006-01-10 | 25 | 3 |
| K041082 | NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER | Newport Medical Instruments, Inc. | 2004-09-07 | 134 | 0 |
| K030780 | NEWPORT E500 WAVE VENTILATOR | Newport Medical Instruments, Inc. | 2004-01-23 | 318 | 0 |
| K992133 | NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 | Newport Medical Instruments, Inc. | 2000-08-04 | 408 | 5 |
| K972833 | E100M VENTILATOR (E100M) | Newport Medical Instruments, Inc. | 1999-09-23 | 785 | 0 |
| K941308 | NEWPORT ELECTRONIC MANOMETER | Newport Medical Instruments, Inc. | 1995-08-25 | 536 | 0 |
| K940739 | NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR | Newport Medical Instruments, Inc. | 1995-03-07 | 383 | 0 |
| K941309 | NEWPORT ELECTRONIC MANOMETER | Newport Medical Instruments, Inc. | 1995-03-06 | 364 | 0 |
| K931542 | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR | Newport Medical Instruments, Inc. | 1993-10-25 | 210 | 0 |
| K901785 | NEWPORT WAVE VENTILATOR MODEL E200 | Newport Medical Instruments, Inc. | 1990-08-10 | 114 | 0 |
| K883809 | NEWPORT VENTILATOR MODEL E150 | Newport Medical Instruments, Inc. | 1989-06-23 | 288 | 0 |
| K860373 | THE M100 AIR/OXYGEN MIXER | Newport Medical Instruments, Inc. | 1986-05-21 | 107 | 0 |
| K860438 | NEWPORT VENTILATOR MODEL E-100 | Newport Medical Instruments, Inc. | 1986-05-06 | 91 | 0 |
| K852108 | NEWPORT VENTILATOR MODEL E-100 | Newport Medical Instruments, Inc. | 1985-09-18 | 126 | 0 |
| K844350 | NEWPORT VENTILATOR MODEL E-100 | Newport Medical Instruments, Inc. | 1984-12-27 | 48 | 0 |
| K820746 | NEWPORT VENTILATOR MODEL E100 | Newport Medical Instruments, Inc. | 1982-04-16 | 28 | 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