Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inspiron Corp. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
44 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860838 | INSPIRON DOUBLE SWIVEL TRACH ADAPTER | Inspiron Corp. | 1986-04-09 | 35 | 0 |
| K850346 | OXYGEN CONCENTRATOR | Inspiron Corp. | 1985-02-04 | 7 | 0 |
| K843932 | VAPOR-PHASE HUMIDIFIER SYS-ADVANCED | Inspiron Corp. | 1984-10-18 | 13 | 0 |
| K840935 | MANUAL RESUSCITATION SYSTEM | Inspiron Corp. | 1984-04-05 | 31 | 0 |
| K841158 | NEBULO 28 NEBULIZER KIT | Inspiron Corp. | 1984-03-30 | 11 | 0 |
| K840418 | INSPIRATORY/EXPIRATORY MUSCLE EXERCIS | Inspiron Corp. | 1984-02-17 | 17 | 0 |
| K834290 | INSPIRON LIQUID OXYGEN SYSTEM | Inspiron Corp. | 1984-02-04 | 58 | 0 |
| K772070 | VENTILATOR SETUP, VOLUME | Inspiron Corp. | 1977-11-15 | 14 | 0 |
| K772072 | MANIFOLD & NEBU. FOR DOUB. LINE MACH. | Inspiron Corp. | 1977-11-15 | 14 | 0 |
| K772068 | MANIFOLD & NEBULIZER, UNIVERSAL | Inspiron Corp. | 1977-11-15 | 14 | 0 |
| K772069 | VOL. VENTILATOR SETUP W/OUT NEBULIZER | Inspiron Corp. | 1977-11-15 | 14 | 0 |
| K772071 | MANIFOLD & NEBU. FOR SINGLE LINE MACH. | Inspiron Corp. | 1977-11-15 | 14 | 0 |
| K770549 | PEDIATRIC ANESTHESIA CIRCUIT | Inspiron Corp. | 1977-03-30 | 9 | 0 |
| K760891 | INSPIRON I.M.V. SET UP | Inspiron Corp. | 1976-12-09 | 44 | 0 |
| K760461 | NOSE CLIP | Inspiron Corp. | 1976-08-26 | 8 | 0 |
| K760313 | KIT, PREP, INSPIRON IV | Inspiron Corp. | 1976-08-04 | 9 | 0 |
| K760082 | BOTTLE, CONDENSATE (#1628) | Inspiron Corp. | 1976-07-16 | 25 | 0 |
| K760037 | HEATER, IMMERSION W/ HUMIDIFIER & NEBUL. | Inspiron Corp. | 1976-07-16 | 31 | 0 |
| K760080 | CANNULA, NASAL, FOR OXYGEN | Inspiron Corp. | 1976-07-15 | 24 | 0 |
| K760081 | FILTER, BACTERIA (#2290) | Inspiron Corp. | 1976-07-15 | 24 | 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