Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Life Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
137 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910699 | LIFE-02 (NON-REFILLABLE CYLINDER) | Life Corp. | 1991-06-18 | 119 | 0 |
| K910434 | LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL | Life Corp. | 1991-06-17 | 137 | 0 |
| K910435 | LIFE OXYGENPAC 6/12 LPM | Life Corp. | 1991-06-17 | 137 | 0 |
| K910201 | LIFE O2 | Life Corp. | 1991-02-01 | 14 | 0 |
| K855092 | LIFE CORP. OXYGEN PAC | Life Corp. | 1986-01-21 | 32 | 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