Dhason Brothers, Inc.: FDA clearances and approvals
Dhason Brothers, Inc. has 14 FDA 510(k) clearances (first 1989, latest 1989), across 5 product codes in 3 review panels. Median 510(k) review time: 35 days.
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 |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | 10 | 10 |
| GDO | Applier, Surgical, Clip | 1 | 1 |
| HXK | Holder, Needle; Orthopedic | 1 | 1 |
| LRW | Scissors, General, Surgical | 1 | 1 |
| LXN | Probe, Test, Heart-Valve | 1 | 1 |
Review panels
- Orthopedic (11)
- General and Plastic Surgery (2)
- Cardiovascular (1)
Most recent Dhason Brothers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890168 | RETRACTOR, SELF-RETAINING | LXH | 1989-02-13 | 35 |
| K890166 | RONGUER-ORTHOPEDIC | LXH | 1989-02-13 | 35 |
| K890165 | FORCEPS-ORTHOPEDIC | LXN | 1989-02-13 | 35 |
| K890164 | HUDSON BRACE W/BURRS | LXH | 1989-02-13 | 35 |
| K890163 | AUSTIN MOORE HALLOW CHISEL | LXH | 1989-02-13 | 35 |
| K890162 | EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD | LXH | 1989-02-13 | 35 |
| K890161 | THOMPSON TYPE RASP W/TOMMY BAR | LXH | 1989-02-13 | 35 |
| K890160 | GOUGES FOR FEMORAL HEADS | LXH | 1989-02-13 | 35 |
| K890158 | RETRACTORS | LXH | 1989-02-13 | 35 |
| K890157 | FORCEPS | LXH | 1989-02-13 | 35 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dhason Brothers, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dhason Brothers, Inc. have?
Dhason Brothers, Inc. has 14 FDA 510(k) clearances (first 1989, latest 1989), across 5 product codes in 3 review panels.
How long does FDA take to clear Dhason Brothers, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dhason Brothers, Inc.'s cleared 510(k)s is 35 days.
What devices does Dhason Brothers, Inc. make?
Its most frequent FDA product codes are LXH (Orthopedic Manual Surgical Instrument, 10); GDO (Applier, Surgical, Clip, 1); HXK (Holder, Needle; Orthopedic, 1).
Has Dhason Brothers, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dhason Brothers, Inc. Related entities may recall under other names.
Next steps
- See all 14 Dhason Brothers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LXH, Dhason Brothers, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.