Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shargh Pharmaceutical Co., Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
343 daysmedian FDA review time
343 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013384 | SHARGHP A.V. FISTULA NEEDLE SET | Shargh Pharmaceutical Co., Inc. | 2002-01-07 | 87 | 0 |
| K895980 | SHARGHP INSULIN SYRINGES | Shargh Pharmaceutical Co., Inc. | 1990-09-07 | 343 | 0 |
| K895810 | SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE | Shargh Pharmaceutical Co., Inc. | 1990-09-07 | 343 | 0 |
| K895812 | SHARGHP INTRAVENOUS CATHETER | Shargh Pharmaceutical Co., Inc. | 1990-09-07 | 343 | 0 |
| K895811 | SHARGHP HYPODERMIC NEEDLE | Shargh Pharmaceutical Co., Inc. | 1990-09-07 | 343 | 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