Pro-Tech Services, Inc.: FDA clearances and approvals
Pro-Tech Services, Inc. has 7 FDA 510(k) clearances (first 1994, latest 2005), across 5 product codes in 2 review panels. Median 510(k) review time: 91 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | 3 | 3 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| GWL | Amplifier, Physiological Signal | 1 | 1 |
Review panels
- Anesthesiology (6)
- Neurology (1)
Most recent Pro-Tech Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053063 | PRO-FLOW MULTIPURPOSE CANNULA | CCK | 2005-12-13 | 42 |
| K033402 | PORTABLE SLEEP DATA RECORDER (PSDR) | MNR | 2004-06-30 | 250 |
| K013905 | MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS | MNR | 2002-04-22 | 147 |
| K982293 | PRESSURE TRANSDUCER AIRFLOW SENSOR | MNR | 1998-07-13 | 12 |
| K972515 | SENSOR AMPLIFIER | GWL | 1997-10-02 | 91 |
| K960851 | THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR | BZQ | 1996-09-17 | 200 |
| K944175 | ADAM SHELL THERMOCOUPLE ASSEMBLY | BZG | 1994-10-14 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Pro-Tech Services, Inc..
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 Pro-Tech Services, Inc. have?
Pro-Tech Services, Inc. has 7 FDA 510(k) clearances (first 1994, latest 2005), across 5 product codes in 2 review panels.
How long does FDA take to clear Pro-Tech Services, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pro-Tech Services, Inc.'s cleared 510(k)s is 91 days.
What devices does Pro-Tech Services, Inc. make?
Its most frequent FDA product codes are MNR (Ventilatory Effort Recorder, 3); BZG (Spirometer, Diagnostic, 1); BZQ (Monitor, Breathing Frequency, 1).
Has Pro-Tech Services, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pro-Tech Services, Inc. Related entities may recall under other names.
Next steps
- See all 7 Pro-Tech Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNR, Pro-Tech Services, 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.