Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intertech/Ohio — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
62 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K895144 | INTERTECH METERED DOSE ELBOW | Intertech/Ohio | 1989-10-19 | 62 | 0 |
| K890346 | INTERTECH UNIVERSAL HYDROPHOBIC FILTER | Intertech/Ohio | 1989-03-01 | 37 | 0 |
| K884525 | PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT | Intertech/Ohio | 1988-12-16 | 50 | 0 |
| K884526 | ADULT RESUSCITATOR WITH MASK AND FILTER | Intertech/Ohio | 1988-11-16 | 20 | 0 |
| K882204 | RESUSCITATOR VALVE ASSEMBLY W/FILTER | Intertech/Ohio | 1988-07-08 | 44 | 0 |
| K880394 | FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR | Intertech/Ohio | 1988-02-29 | 31 | 0 |
| K863033 | PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS | Intertech/Ohio | 1986-08-20 | 9 | 0 |
| K862020 | HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER | Intertech/Ohio | 1986-06-30 | 33 | 0 |
| K860650 | 90 DEGREE ELBOW & STRAIGHT CONNECTOR | Intertech/Ohio | 1986-03-28 | 35 | 0 |
| K861056 | STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG | Intertech/Ohio | 1986-03-27 | 8 | 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