Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jayco Pharmaceuticals — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
159 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K844689 | ENDOSCOPIC MANUAL AIR INSUFFLATOR | Jayco Pharmaceuticals | 1985-01-02 | 30 | 0 |
| K844691 | ENDOSCOPIC ASPIRATION CATHETER SET | Jayco Pharmaceuticals | 1985-01-02 | 30 | 0 |
| K844690 | ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT | Jayco Pharmaceuticals | 1985-01-02 | 30 | 0 |
| K842009 | ABDOMINAL PARACENTESIS TRAY | Jayco Pharmaceuticals | 1984-10-23 | 159 | 0 |
| K842001 | LIVER BIOPSY TRAY | Jayco Pharmaceuticals | 1984-10-15 | 152 | 0 |
| K841258 | FOREIGN BODY PROTECTOR | Jayco Pharmaceuticals | 1984-07-09 | 105 | 0 |
| K840800 | POLYP-SAVER SLEVE | Jayco Pharmaceuticals | 1984-03-23 | 29 | 0 |
| K830781 | ENDO-GUARD | Jayco Pharmaceuticals | 1983-03-31 | 20 | 0 |
| K810875 | FECAL STAINING KIT | Jayco Pharmaceuticals | 1981-05-01 | 31 | 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