Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suru Chemicals & Pharmaceuticals, Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
210 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K811006 | SOLUTION ADMINISTRATION SET | Suru Chemicals & Pharmaceuticals, Ltd. | 1981-06-02 | 49 | 0 |
| K802170 | SURU BLOOD COLLECTION SET | Suru Chemicals & Pharmaceuticals, Ltd. | 1981-04-06 | 210 | 0 |
| K802169 | SURU INFUSION SET TYPE J | Suru Chemicals & Pharmaceuticals, Ltd. | 1981-04-06 | 210 | 0 |
| K780655 | STERILE INFUSION SET TYPE S | Suru Chemicals & Pharmaceuticals, Ltd. | 1978-07-19 | 90 | 0 |
| K780656 | STERILE INFUSION SET TYPE J | Suru Chemicals & Pharmaceuticals, Ltd. | 1978-07-19 | 90 | 0 |
| K780657 | STERILE BLOOD COLLECTION SET | Suru Chemicals & Pharmaceuticals, Ltd. | 1978-07-19 | 90 | 0 |
| K780658 | STERILE BLOOD ADMINISTRATION SET | Suru Chemicals & Pharmaceuticals, Ltd. | 1978-07-19 | 90 | 0 |
| K772008 | SCALP VEIN SETS | Suru Chemicals & Pharmaceuticals, Ltd. | 1978-01-03 | 75 | 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