Laivan Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Laivan Corp.” (first 1988, latest 1993), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 74 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 |
|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | 3 | 3 |
| KGX | Tape And Bandage, Adhesive | 2 | 2 |
| FYA | Gown, Surgical | 1 | 1 |
Review panels
Most recent Laivan Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923815 | TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS | FYA | 1993-03-31 | 244 |
| K890940 | MODIFIED LABELING FOR POLYDERM WBC(TM) | NAD | 1989-04-17 | 54 |
| K885205 | AQUADERM | KGX | 1989-03-29 | 100 |
| K880153 | POLYDERM A+B(TM) | NAD | 1988-04-13 | 91 |
| K880964 | POLYDERM PEC(TM), POROUS ELASTIC COVER | KGX | 1988-03-17 | 9 |
| K880206 | POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER | NAD | 1988-03-11 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Laivan Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Laivan Corp.?
FDA lists 6 510(k) clearances under the applicant name “Laivan Corp.” (first 1988, latest 1993), across 3 product codes in 2 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 Laivan Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laivan Corp. is 74 days.
Which FDA product codes appear under Laivan Corp.?
The most frequent FDA product codes under this applicant name are NAD (Dressing, Wound, Occlusive, 3); KGX (Tape And Bandage, Adhesive, 2); FYA (Gown, Surgical, 1).
Next steps
- See all 6 Laivan Corp. clearances with predicates and recalls
- Run predicate analysis for product code NAD, Laivan Corp.'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.