Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inhalation Plastics — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
180 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945565 | SPIRO-FLEX | Inhalation Plastics | 1995-01-13 | 119 | 0 |
| K914686 | THERMO-FLOW SET | Inhalation Plastics | 1992-04-15 | 180 | 0 |
| K901315 | AEROMIST II NEBULIZER | Inhalation Plastics | 1990-09-10 | 173 | 0 |
| K900990 | FILT-R-ALL BACTERIAL/VIRAL FILTER | Inhalation Plastics | 1990-04-19 | 48 | 0 |
| K900594 | ANESTHESIA BREATHING CIRCUIT | Inhalation Plastics | 1990-03-15 | 36 | 0 |
| K896832 | FILT-R-ALL BACTERIAL FILTER | Inhalation Plastics | 1990-01-22 | 48 | 0 |
| K874659 | STERILIZATION OF DEVICES BY RADIATION | Inhalation Plastics | 1988-02-02 | 105 | 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