Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jain Surgical Equipment, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913896 | JAIN BLOOD SHIELD | Jain Surgical Equipment, Inc. | 1992-03-06 | 189 | 0 |
| K911077 | JAIN SUTURE PACKAGE COUNTER | Jain Surgical Equipment, Inc. | 1991-05-31 | 81 | 0 |
| K911076 | JAIN QUICK COUNT | Jain Surgical Equipment, Inc. | 1991-05-30 | 80 | 0 |
| K905105 | JAIN SUTURE/VESIBAND ORGANIZER | Jain Surgical Equipment, Inc. | 1991-01-31 | 79 | 0 |
| K904536 | JAIN GRAFT ASSIST | Jain Surgical Equipment, Inc. | 1990-11-29 | 56 | 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