Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pro-Tech Services, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
250 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053063 | PRO-FLOW MULTIPURPOSE CANNULA | Pro-Tech Services, Inc. | 2005-12-13 | 42 | 0 |
| K033402 | PORTABLE SLEEP DATA RECORDER (PSDR) | Pro-Tech Services, Inc. | 2004-06-30 | 250 | 0 |
| K013905 | MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS | Pro-Tech Services, Inc. | 2002-04-22 | 147 | 0 |
| K982293 | PRESSURE TRANSDUCER AIRFLOW SENSOR | Pro-Tech Services, Inc. | 1998-07-13 | 12 | 0 |
| K972515 | SENSOR AMPLIFIER | Pro-Tech Services, Inc. | 1997-10-02 | 91 | 0 |
| K960851 | THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTO | Pro-Tech Services, Inc. | 1996-09-17 | 200 | 0 |
| K944175 | ADAM SHELL THERMOCOUPLE ASSEMBLY | Pro-Tech Services, Inc. | 1994-10-14 | 49 | 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