Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DAH · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
47 daysmedian FDA review time
260 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931247 | TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 | Helena Laboratories | 1993-04-27 | 47 | 0 |
| K905149 | TITAN GEL | Helena Laboratories | 1991-01-03 | 49 | 0 |
| K901805 | REP(R) IMMUNOFIX | Helena Laboratories | 1990-06-06 | 47 | 0 |
| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | Orion Diagnostica, Inc. | 1988-10-27 | 30 | 0 |
| K883494 | TECHNICON DPA-1 IMMUNOGLOBULIN G | Technicon Instruments Corp. | 1988-09-07 | 22 | 0 |
| K854944 | TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT | Abbott Laboratories | 1986-08-27 | 260 | 0 |
| K862184 | DAKO ITA, IMMUNOGLOBULIN M (IGM) | Dako Corp. | 1986-08-19 | 71 | 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