Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PIO — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
225 daysmedian FDA review time
274 days90th percentile
9clearances 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 |
| K233190 | ENFit Adaptor | Jiangsu Caina Medical Co.,Ltd | 2024-01-18 | 112 | 0 |
| K220165 | Enteral Transition Adaptor | GBUK Group, Ltd. | 2022-10-21 | 274 | 0 |
| K162254 | Cedic Enteral ENFit Transition Connectors | Cedic S.R.L. | 2017-05-04 | 267 | 0 |
| K151237 | Nutrisafe 2- ENFit Adaptor | Vygon | 2016-02-09 | 274 | 0 |
| K151628 | Medline ENFit Connectors | Medline Industries, Inc. | 2015-07-24 | 37 | 1 |
| K150034 | AMT Enteral Transition Adapters | Applied Medical Technology, Inc. | 2015-06-09 | 151 | 0 |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medic | Cedic S.R.L. | 2015-04-02 | 90 | 0 |
| K140581 | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC E | Cedic S.R.L. | 2014-10-17 | 225 | 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