Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cair Lgl — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
171 daysmedian FDA review time
263 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231299 | Nutricair enteral ENFit adapter: ENFit male – stepped/Christ | Cair Lgl | 2024-01-22 | 263 | 0 |
| K231300 | Nutricair Enteral Syringe with ENFit | Cair Lgl | 2023-10-06 | 155 | 0 |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | 2022-06-09 | 252 | 0 |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | Cair Lgl | 2021-11-02 | 246 | 0 |
| K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000) | Cair Lgl | 2017-09-01 | 140 | 0 |
| K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle- | Cair Lgl | 2017-08-15 | 123 | 0 |
| K171132 | Carefusion NeutraClear Needle-free connector | Cair Lgl | 2017-07-31 | 105 | 0 |
| K133073 | CAIR DRIVE, NEUTRACLEAR | Cair Lgl | 2014-03-20 | 171 | 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