Mercury Medical: FDA clearances and approvals
Mercury Medical has 16 FDA 510(k) clearances (first 1994, latest 2014), across 11 product codes in 3 review panels. Median 510(k) review time: 142 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 77 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 4 | 4 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 2 | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| BXR | Meter, Airway Pressure (Inspiratory Force) | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
| GXI | Probe, Radiofrequency Lesion | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (14)
- General Hospital (1)
- Neurology (1)
Most recent Mercury Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142096 | T-PIECE RESUSCITATOR | BTL | 2014-10-17 | 77 |
| K093913 | MERCURY MEDICAL T-PIECE RESUSCITATOR | BTL | 2010-04-06 | 105 |
| K090710 | MERCURY CPAP | BYE | 2009-08-20 | 155 |
| K083056 | NEO-STAT CO2 <KG | CCK | 2009-02-23 | 132 |
| K032593 | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER | BXR | 2004-02-03 | 165 |
| K031814 | STATCO2METER, MODEL 10-55372 | CCK | 2003-08-14 | 63 |
| K031411 | MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 | CCK | 2003-07-30 | 86 |
| K021576 | MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 | CCK | 2002-11-04 | 174 |
| K001714 | MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 | NHK | 2000-11-03 | 151 |
| K000073 | MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA | GXI | 2000-03-01 | 51 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mercury Medical.
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.
Frequently asked questions
How many FDA 510(k) clearances does Mercury Medical have?
Mercury Medical has 16 FDA 510(k) clearances (first 1994, latest 2014), across 11 product codes in 3 review panels.
How long does FDA take to clear Mercury Medical's 510(k)s?
The median time from FDA receipt to decision across Mercury Medical's cleared 510(k)s is 142 days.
What devices does Mercury Medical make?
Its most frequent FDA product codes are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 4); BTL (Ventilator, Emergency, Powered (Resuscitator), 2); BTM (Ventilator, Emergency, Manual (Resuscitator), 2).
Has Mercury Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching Mercury Medical. Related entities may recall under other names.
Next steps
- See all 16 Mercury Medical clearances with predicates and recalls
- Run predicate analysis for product code CCK, Mercury Medical'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.