Transcorp: FDA filings under this applicant name
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Transcorp” (first 1989, latest 2013), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 128 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 | 1 | 154 |
| 2013 | 1 | 443 |
| 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 4 | 4 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- General Hospital (6)
- Orthopedic (4)
Most recent Transcorp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121178 | TRANSCORP ACIF SYSTEM | ODP | 2013-07-05 | 443 |
| K113352 | TRANSCORP SPINAL ACCESS SYSTEM | HRX | 2012-04-16 | 154 |
| K092794 | TRANSCORP ACIF SYSTEM | ODP | 2010-09-13 | 367 |
| K092695 | TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2010-05-21 | 261 |
| K922439 | LATEX EXAMINATION GLOVES | LYY | 1993-05-13 | 356 |
| K915189 | STERILETX POWDER FREE LATEX EXAMINATION GLOVES | LYY | 1992-02-27 | 101 |
| K904662 | SRI JOHANI LATEX SURGEONS GLOVES | KGO | 1991-01-11 | 88 |
| K903069 | KLEARTEX LATEX SURGICAL GLOVES | KGO | 1990-08-07 | 26 |
| K894569 | MEDPRIDE LATEX EXAMINATION GLOVES | LYY | 1989-08-24 | 34 |
| K891120 | TEXMED LATEX EXAMINATION GLOVE | LYY | 1989-03-24 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Transcorp.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Transcorp (6)
- Transcorp, Inc. (4)
Frequently asked questions
How many FDA 510(k) clearances are listed under Transcorp?
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Transcorp” (first 1989, latest 2013), across 5 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 Transcorp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Transcorp is 128 days.
Which FDA product codes appear under Transcorp?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); KGO (Surgeon'S Gloves, 2); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2).
Next steps
- See all 10 Transcorp clearances with predicates and recalls
- Run predicate analysis for product code LYY, Transcorp'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.