Vortran Medical Technology 1, Inc.: FDA clearances and approvals
Vortran Medical Technology 1, Inc. has 28 FDA 510(k) clearances (first 1984, latest 2021), across 6 product codes in 1 review panel. Median 510(k) review time: 135 days. Since 2017 its median was 178 days, against 234 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Vortran Medical Technology 1, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 263 |
| 2017 | 1 | 168 |
| 2018 | 1 | 154 |
| 2019 | 1 | 391 |
| 2020 | 0 | — |
| 2021 | 1 | 189 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Vortran Medical Technology 1, Inc.'s cleared 510(k)s took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 234 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 12 | 12 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 6 | 6 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 3 | 3 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 3 | 3 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | 3 | 3 |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 | 1 |
Review panels
- Anesthesiology (28)
Most recent Vortran Medical Technology 1, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202219 | VORTRAN GO2VENT with PEEP Valve | BTL | 2021-02-11 | 189 |
| K182292 | VORTRAN APM-Plus | CAP | 2019-09-18 | 391 |
| K173914 | VORTRAN Cuff Inflator (VCI) | BSK | 2018-05-25 | 154 |
| K162968 | VORTRAN GO2VENT | BTL | 2017-04-10 | 168 |
| K153733 | VORTRAN Manometer | CAP | 2016-09-16 | 263 |
| K103639 | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC | CAP | 2011-09-15 | 276 |
| K073261 | VAR MONITOR | BTL | 2008-05-23 | 185 |
| K041473 | VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM | BTL | 2004-07-15 | 43 |
| K003684 | PERCUSSIVENEB, MODEL PN-2001 | NHJ | 2001-02-23 | 86 |
| K001430 | RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 | BTL | 2000-07-05 | 61 |
18 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-04-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Vortran Medical Technology 1, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Vortran Medical Technology 1, Inc. have?
Vortran Medical Technology 1, Inc. has 28 FDA 510(k) clearances (first 1984, latest 2021), across 6 product codes in 1 review panel.
How long does FDA take to clear Vortran Medical Technology 1, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vortran Medical Technology 1, Inc.'s cleared 510(k)s is 135 days. Since 2017: 178 days, versus 234 days for all cleared 510(k)s in the same product codes.
What devices does Vortran Medical Technology 1, Inc. make?
Its most frequent FDA product codes are CAF (Nebulizer (Direct Patient Interface), 12); BTL (Ventilator, Emergency, Powered (Resuscitator), 6); CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm), 3).
Has Vortran Medical Technology 1, Inc. had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Vortran Medical Technology 1, Inc; the most recent began 2017-04-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 28 Vortran Medical Technology 1, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Vortran Medical Technology 1, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.