Indus Medicare , Ltd.: FDA clearances and approvals
Indus Medicare , Ltd. has 8 FDA 510(k) clearances (first 1999, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time: 66 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 7 | 7 |
| LTZ | Condom With Nonoxynol-9 | 1 | 1 |
Review panels
Most recent Indus Medicare , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022614 | INVIGRA | HIS | 2003-04-08 | 245 |
| K020223 | INVIGRA | HIS | 2002-03-04 | 41 |
| K000040 | INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED | HIS | 2000-03-21 | 75 |
| K000039 | INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED | HIS | 2000-03-21 | 75 |
| K000038 | INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED | HIS | 2000-03-21 | 75 |
| K993693 | INVIGRA | HIS | 1999-12-29 | 57 |
| K992438 | INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) | LTZ | 1999-08-02 | 11 |
| K991374 | INVIGRA | HIS | 1999-06-15 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Indus Medicare , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Indus Medicare , Ltd. have?
Indus Medicare , Ltd. has 8 FDA 510(k) clearances (first 1999, latest 2003), across 2 product codes in 1 review panel.
How long does FDA take to clear Indus Medicare , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Indus Medicare , Ltd.'s cleared 510(k)s is 66 days.
What devices does Indus Medicare , Ltd. make?
Its most frequent FDA product codes are HIS (Condom, 7); LTZ (Condom With Nonoxynol-9, 1).
Has Indus Medicare , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Indus Medicare , Ltd. Related entities may recall under other names.
Next steps
- See all 8 Indus Medicare , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Indus Medicare , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.