Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Indus Medicare , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
245 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022614 | INVIGRA | Indus Medicare , Ltd. | 2003-04-08 | 245 | 0 |
| K020223 | INVIGRA | Indus Medicare , Ltd. | 2002-03-04 | 41 | 0 |
| K000040 | INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED | Indus Medicare , Ltd. | 2000-03-21 | 75 | 0 |
| K000039 | INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED | Indus Medicare , Ltd. | 2000-03-21 | 75 | 0 |
| K000038 | INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED | Indus Medicare , Ltd. | 2000-03-21 | 75 | 0 |
| K993693 | INVIGRA | Indus Medicare , Ltd. | 1999-12-29 | 57 | 0 |
| K992438 | INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) | Indus Medicare , Ltd. | 1999-08-02 | 11 | 0 |
| K991374 | INVIGRA | Indus Medicare , Ltd. | 1999-06-15 | 55 | 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