Biocontrol Technology, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Biocontrol Technology, Inc.” (first 1996, latest 1998), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | 2 |
| GZC | Stimulator, Neuromuscular, Implanted | 1 | 0 |
Review panels
Most recent Biocontrol Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974475 | THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 | LJT | 1998-03-02 | 96 |
| K960350 | THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 | LJT | 1996-04-15 | 81 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P950035 | PMA | NEUROCONTROL FREEHAND SYSTEM(R) | 1997-08-15 |
Recalls
openFDA lists no recalls under a recalling firm named Biocontrol Technology, Inc..
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 Biocontrol Technology, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Biocontrol Technology, Inc.” (first 1996, latest 1998), plus 1 PMA decision, across 2 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 Biocontrol Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biocontrol Technology, Inc. is 88 days.
Which FDA product codes appear under Biocontrol Technology, Inc.?
The most frequent FDA product codes under this applicant name are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 2); GZC (Stimulator, Neuromuscular, Implanted, 1).
Next steps
- See all 2 Biocontrol Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Biocontrol Technology, Inc.'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.