Palex Intl. SA: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Palex Intl. SA” (first 1990, latest 1991), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
| EXD | Irrigator, Ostomy | 1 | 1 |
Review panels
Most recent Palex Intl. SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905108 | CONTORNO(R), MODELS E AND ST | GEI | 1991-02-04 | 83 |
| K904586 | PALEX IRRIGATION SET | EXD | 1990-12-28 | 80 |
| K903224 | EPISENSOR | BSP | 1990-12-24 | 154 |
| K902642 | CONTORNO (TM) | GEI | 1990-08-07 | 54 |
| K901680 | BAUMAN RIGID LARYNGOSCOPE | CCW | 1990-07-12 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Palex Intl. SA.
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.
- Palex Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Palex Intl. SA?
FDA lists 5 510(k) clearances under the applicant name “Palex Intl. SA” (first 1990, latest 1991), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Palex Intl. SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Palex Intl. SA is 83 days.
Which FDA product codes appear under Palex Intl. SA?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 1); CCW (Laryngoscope, Rigid, 1).
Next steps
- See all 5 Palex Intl. SA clearances with predicates and recalls
- Run predicate analysis for product code GEI, Palex Intl. SA'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.