Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inhal-O-Tech Medical Plastic · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
64 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K781741 | MASK, BI FLO NASAL OXYGEN | Inhal-O-Tech Medical Plastic | 1978-12-01 | 55 | 0 |
| K781394 | DISPOSABLE INCENTIVE SPIROMETER | Inhal-O-Tech Medical Plastic | 1978-10-16 | 63 | 0 |
| K781395 | DISPOSABLE AEROSOL T BRIGGS ADAPTOR | Inhal-O-Tech Medical Plastic | 1978-08-31 | 17 | 0 |
| K770353 | DISPOSABLE TEMPERATURE PROBE | Inhal-O-Tech Medical Plastic | 1977-03-16 | 22 | 0 |
| K770354 | TUBING, AEROSAL, DISPOSABLE | Inhal-O-Tech Medical Plastic | 1977-03-16 | 22 | 0 |
| K760329 | MASK, DISPOSABLE OXYGEN THERAPY | Inhal-O-Tech Medical Plastic | 1976-09-30 | 64 | 0 |
| K760330 | CANNULA, DISPOSABLE OXYGEN TTHERAPY | Inhal-O-Tech Medical Plastic | 1976-08-04 | 7 | 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