Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vortran Medical Technology 1, Inc. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
145 daysmedian FDA review time
276 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202219 | VORTRAN GO2VENT with PEEP Valve | Vortran Medical Technology 1, Inc. | 2021-02-11 | 189 | 0 |
| K182292 | VORTRAN APM-Plus | Vortran Medical Technology 1, Inc. | 2019-09-18 | 391 | 0 |
| K173914 | VORTRAN Cuff Inflator (VCI) | Vortran Medical Technology 1, Inc. | 2018-05-25 | 154 | 0 |
| K162968 | VORTRAN GO2VENT | Vortran Medical Technology 1, Inc. | 2017-04-10 | 168 | 0 |
| K153733 | VORTRAN Manometer | Vortran Medical Technology 1, Inc. | 2016-09-16 | 263 | 0 |
| K103639 | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY | Vortran Medical Technology 1, Inc. | 2011-09-15 | 276 | 0 |
| K073261 | VAR MONITOR | Vortran Medical Technology 1, Inc. | 2008-05-23 | 185 | 0 |
| K041473 | VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM | Vortran Medical Technology 1, Inc. | 2004-07-15 | 43 | 2 |
| K003684 | PERCUSSIVENEB, MODEL PN-2001 | Vortran Medical Technology 1, Inc. | 2001-02-23 | 86 | 0 |
| K001430 | RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 200 | Vortran Medical Technology 1, Inc. | 2000-07-05 | 61 | 2 |
| K982016 | PIPER IPPB MODEL 2055 | Vortran Medical Technology 1, Inc. | 1998-11-03 | 148 | 0 |
| K981726 | PERCUSSIVETECH HF, MODEL 2001 | Vortran Medical Technology 1, Inc. | 1998-09-17 | 125 | 0 |
| K973975 | RESPIRTECHPRO | Vortran Medical Technology 1, Inc. | 1998-06-12 | 235 | 2 |
| K963910 | HEART NEBULIZER #100609 | Vortran Medical Technology 1, Inc. | 1996-12-16 | 77 | 0 |
| K943600 | UNIHEART | Vortran Medical Technology 1, Inc. | 1994-10-13 | 80 | 0 |
| K944643 | AUTONEB ACCESSORY CROSS (AAC) | Vortran Medical Technology 1, Inc. | 1994-10-04 | 13 | 0 |
| K935693 | AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT | Vortran Medical Technology 1, Inc. | 1994-08-25 | 269 | 0 |
| K933915 | VENTI-GENTLE-HALER(TM) | Vortran Medical Technology 1, Inc. | 1993-10-28 | 79 | 0 |
| K924667 | AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY) | Vortran Medical Technology 1, Inc. | 1993-08-26 | 344 | 0 |
| K924649 | SOFT-MIST(TM) | Vortran Medical Technology 1, Inc. | 1993-05-17 | 244 | 0 |
| K923596 | HEART NEBULIZER | Vortran Medical Technology 1, Inc. | 1992-10-15 | 87 | 0 |
| K920443 | MININEB | Vortran Medical Technology 1, Inc. | 1992-07-02 | 150 | 0 |
| K920332 | HEART NUBULIZER | Vortran Medical Technology 1, Inc. | 1992-05-26 | 124 | 0 |
| K911759 | VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER | Vortran Medical Technology 1, Inc. | 1991-09-10 | 145 | 0 |
| K896696 | (HEART) NEBULIZER | Vortran Medical Technology 1, Inc. | 1990-02-12 | 76 | 0 |
| K873477 | INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) | Vortran Medical Technology 1, Inc. | 1987-10-09 | 39 | 0 |
| K842988 | VMT GENTLE-HALER | Vortran Medical Technology 1, Inc. | 1984-08-07 | 8 | 0 |
| K841894 | VMT HAND HELD NEBULIZER | Vortran Medical Technology 1, Inc. | 1984-06-05 | 29 | 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