Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Delphi Consulting Group — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
203 daysmedian FDA review time
398 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983680 | TRINITY II SINGLE CHAMBER DVT PUMP | Delphi Consulting Group | 1999-04-28 | 190 | 0 |
| K963957 | TRINITY DVT SYSTEM | Delphi Consulting Group | 1997-11-04 | 398 | 0 |
| K970014 | TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) | Delphi Consulting Group | 1997-08-06 | 216 | 0 |
| K961937 | SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION | Delphi Consulting Group | 1996-12-09 | 203 | 0 |
| K961301 | E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120 | Delphi Consulting Group | 1996-06-11 | 68 | 0 |
| K954489 | TRINITY SLEEVE(S) | Delphi Consulting Group | 1996-02-22 | 148 | 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