Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Deltec, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
205 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031361 | CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP | Deltec, Inc. | 2003-05-23 | 23 | 1 |
| K030983 | TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS | Deltec, Inc. | 2003-04-25 | 28 | 0 |
| K022221 | TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETE | Deltec, Inc. | 2003-01-30 | 205 | 0 |
| K021999 | GRIPPER PLUS NEEDLE | Deltec, Inc. | 2002-08-13 | 55 | 0 |
| K020655 | DELTEC INSULIN INFUSION PUMP AND ACCESSORIES | Deltec, Inc. | 2002-08-13 | 165 | 6 |
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