Innolatex Sdn. Bhd: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Innolatex Sdn. Bhd” (first 2000, latest 2006), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 8 | 8 |
| LTZ | Condom With Nonoxynol-9 | 1 | 1 |
Review panels
Most recent Innolatex Sdn. Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053367 | MALE NATURAL RUBBER LATEX CONDOM | HIS | 2006-02-21 | 78 |
| K041837 | INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED | HIS | 2004-09-24 | 79 |
| K012964 | 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM | HIS | 2001-11-09 | 66 |
| K012962 | DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM | HIS | 2001-11-09 | 66 |
| K012665 | ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT | HIS | 2001-11-09 | 88 |
| K012664 | ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT | HIS | 2001-11-09 | 88 |
| K010919 | MALE NATURAL RUBBER LATEX CONDOM | HIS | 2001-06-15 | 80 |
| K010178 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | LTZ | 2001-04-27 | 98 |
| K002393 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM | HIS | 2000-12-19 | 134 |
Recalls
openFDA lists no recalls under a recalling firm named Innolatex Sdn. Bhd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Innolatex (Thailand) Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innolatex Sdn. Bhd?
FDA lists 9 510(k) clearances under the applicant name “Innolatex Sdn. Bhd” (first 2000, latest 2006), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Innolatex Sdn. Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innolatex Sdn. Bhd is 80 days.
Which FDA product codes appear under Innolatex Sdn. Bhd?
The most frequent FDA product codes under this applicant name are HIS (Condom, 8); LTZ (Condom With Nonoxynol-9, 1).
Next steps
- See all 9 Innolatex Sdn. Bhd clearances with predicates and recalls
- Run predicate analysis for product code HIS, Innolatex Sdn. Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.