Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gibeck Respiration — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
70 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881657 | HUMID-VENT FILTER | Gibeck Respiration | 1988-06-24 | 70 | 0 |
| K881656 | HUMID-VENT 2 S FLEX | Gibeck Respiration | 1988-06-16 | 62 | 0 |
| K881644 | HUMID-VENT 2 S | Gibeck Respiration | 1988-06-10 | 56 | 0 |
| K873768 | HUMID-VENT(R) 2 PORT | Gibeck Respiration | 1987-11-24 | 69 | 0 |
| K873767 | HUMID-VENT(R) MINI | Gibeck Respiration | 1987-11-06 | 51 | 0 |
| K872153 | STOM-VENT | Gibeck Respiration | 1987-08-03 | 60 | 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