Cair Lgl: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cair Lgl” (first 2014, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 163 days. Since 2017 the median was 155 days, against 223 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 171 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 3 | 123 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 246 |
| 2022 | 1 | 252 |
| 2023 | 1 | 155 |
| 2024 | 1 | 263 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cair Lgl took a median 155 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 4 | 4 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 2 | 2 |
| PIO | Enteral Specific Transition Connectors | 1 | 1 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 1 | 1 |
Review panels
Most recent Cair Lgl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231299 | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector | PIO | 2024-01-22 | 263 |
| K231300 | Nutricair Enteral Syringe with ENFit | PNR | 2023-10-06 | 155 |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | PIF | 2022-06-09 | 252 |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | PIF | 2021-11-02 | 246 |
| K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000) | FPA | 2017-09-01 | 140 |
| K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) | FPA | 2017-08-15 | 123 |
| K171132 | Carefusion NeutraClear Needle-free connector | FPA | 2017-07-31 | 105 |
| K133073 | CAIR DRIVE, NEUTRACLEAR | FPA | 2014-03-20 | 171 |
Recalls
openFDA lists no recalls under a recalling firm named Cair Lgl.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cair Lgl?
FDA lists 8 510(k) clearances under the applicant name “Cair Lgl” (first 2014, latest 2024), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cair Lgl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cair Lgl is 163 days. Since 2017: 155 days, versus 223 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cair Lgl?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 4); PIF (Gastrointestinal Tubes With Enteral Specific Connectors, 2); PIO (Enteral Specific Transition Connectors, 1).
Next steps
- See all 8 Cair Lgl clearances with predicates and recalls
- Run predicate analysis for product code FPA, Cair Lgl's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.