Bionix Development Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under 2 spellings of the applicant name “Bionix Development Corp.” (first 1990, latest 2018), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 81 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 | 90 |
| 2013 | 1 | 122 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 117 |
| 2017 | 0 | — |
| 2018 | 1 | 231 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bionix Development Corp. took a median 231 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 10 | 10 |
| HFX | Clamp, Circumcision | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| PDH | Blanket, Neonatal Phototherapy | 1 | 1 |
Review panels
Most recent Bionix Development Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180605 | GastroFlush | KNT | 2018-10-24 | 231 |
| K153270 | TruGuard Custom Tongue and Jaw Positioner | IYE | 2016-03-08 | 117 |
| K123411 | LITTLE ANGELS SWADDLING BLANKET | PDH | 2013-03-07 | 122 |
| K120335 | EMBRACE THERMOPLASTIC | IYE | 2012-05-03 | 90 |
| K100691 | OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 | IYE | 2010-05-11 | 62 |
| K100264 | T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 | IYE | 2010-04-09 | 71 |
| K050701 | THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 | IYE | 2005-04-01 | 14 |
| K040773 | PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM | IYE | 2004-04-09 | 14 |
| K030051 | VERSABOARD, MODEL 7040 | IYE | 2003-04-04 | 88 |
| K933614 | PITUITARY BOARD | IYE | 1993-10-07 | 80 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bionix Development 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.
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:
- Bionix Development Corp. (12)
- Bionix Development Corporation (1)
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.
- Bionix Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bionix Development Corp.?
FDA lists 13 510(k) clearances under 2 spellings of the applicant name “Bionix Development Corp.” (first 1990, latest 2018), across 4 product codes in 4 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 Bionix Development Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bionix Development Corp. is 81 days.
Which FDA product codes appear under Bionix Development Corp.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 10); HFX (Clamp, Circumcision, 1); KNT (Tubes, Gastrointestinal (And Accessories), 1).
Next steps
- See all 13 Bionix Development Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Bionix Development 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 (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.