Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GCD · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
336 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952470 | ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. | R-Group Intl. | 1995-11-28 | 186 | 0 |
| K940198 | L-CATH CONNECTOR ASSEMBLY | Luther Medical Products, Inc. | 1994-12-15 | 336 | 0 |
| K863446 | ANGIOMED HIGH PRESSURE CONNECTORS | Angiomed U.S., Inc. | 1986-09-23 | 15 | 0 |
| K851196 | INCISION DRAIN | Sil-Med Corp. | 1985-06-04 | 70 | 0 |
| K851921 | Y CONNECTOR | Sil-Med Corp. | 1985-05-17 | 15 | 0 |
| K760382 | CONNECTORS | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760524 | CATHETER CONNECTOR, ARGYLE TUBING | Sherwood Medical Industries | 1976-11-02 | 68 | 0 |
| K760203 | TUBE, STERILE NON-CONDUCTIVE CONNECTING | Ipco Corp. | 1976-07-19 | 11 | 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