Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QEH · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
204 daysmedian FDA review time
354 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241385 | Omnifix Syringe NRFit | B.Braun Medical, Inc. | 2024-07-13 | 59 | 0 |
| K213800 | Artiglass NRFitTM Tip L.O.R. Glass Syringes | Artiglass Srl | 2022-05-19 | 164 | 0 |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | International Medical Industries, Inc. | 2020-12-16 | 240 | 0 |
| K192538 | BD Syringe NRFit Lok and BD Syringe NRFit Slip | Becton, Dickinson and Company | 2020-09-04 | 354 | 0 |
| K181374 | NRFit Syringe | Jiangsu Caina Medical Co.,Ltd | 2018-12-14 | 204 | 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