Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GJE — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
35 daysmedian FDA review time
529 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | Customed, Inc. | 1996-09-27 | 87 | 0 |
| K925468 | JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT | J.J. Skinner, Inc. | 1994-04-11 | 529 | 0 |
| K780303 | AUTO ISO-FILTER COLLECTION TUBE CAP | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-03-30 | 35 | 0 |
| K771489 | RTERIAL BLOOD SAMPLING KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-22 | 17 | 0 |
| K771370 | ICROTAINEO BRAND TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-03 | 9 | 1 |
| K761177 | SODIUM CITRATE | Bio/Data Corp. | 1977-01-10 | 40 | 0 |
| K760086 | TRAY, BLOOD SAMPLING (PULSATOR II) | Concord Laboratories, Inc. | 1976-07-16 | 25 | 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