Advanced Biosearch Assn.: FDA clearances and approvals
Advanced Biosearch Assn. has 22 FDA 510(k) clearances (first 1983, latest 1991), across 14 product codes in 6 review panels. Median 510(k) review time: 82 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 | 4 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 3 | 3 |
| HCH | Clip, Aneurysm | 2 | 2 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 2 | 2 |
| MBV | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
| HCI | Applier, Aneurysm Clip | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Plus 4 more product codes.
Review panels
- Orthopedic (14)
- Neurology (3)
- General and Plastic Surgery (2)
- Cardiovascular (1)
- Dental (1)
- General Hospital (1)
Most recent Advanced Biosearch Assn. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905514 | AUTOGENESIS(TM) AUTOMATOR | KTT | 1991-04-02 | 116 |
| K883888 | CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. | DXK | 1988-12-12 | 88 |
| K854770 | MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM | KWP | 1986-02-11 | 76 |
| K855030 | CHAMPY BONE PLATES & BONE SCREWS | JEY | 1986-01-30 | 45 |
| K855031 | MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P | HWC | 1986-01-21 | 36 |
| K853916 | P.M. HIP-FEMORAL PROSTHESIS | JDI | 1985-12-27 | 95 |
| K852839 | FREEMAN HIP | JDI | 1985-10-29 | 116 |
| K853418 | SAFTI-BRACELET | KMK | 1985-09-20 | 37 |
| K852517 | CLS HIP PROSTHESIS | JDI | 1985-09-18 | 97 |
| K852699 | FREEMAN ACETABULAR CUP | KWA | 1985-09-05 | 71 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advanced Biosearch Assn..
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 Advanced Biosearch Assn. have?
Advanced Biosearch Assn. has 22 FDA 510(k) clearances (first 1983, latest 1991), across 14 product codes in 6 review panels.
How long does FDA take to clear Advanced Biosearch Assn.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Biosearch Assn.'s cleared 510(k)s is 82 days.
What devices does Advanced Biosearch Assn. make?
Its most frequent FDA product codes are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 4); KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), 3); HCH (Clip, Aneurysm, 2).
Has Advanced Biosearch Assn. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Biosearch Assn. Related entities may recall under other names.
Next steps
- See all 22 Advanced Biosearch Assn. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Advanced Biosearch Assn.'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.