Andronic Devices, Ltd.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Andronic Devices, Ltd.” (first 1987, latest 1994), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 129 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 |
|---|---|---|---|
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | 4 | 4 |
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| FQO | Table, Operating-Room, Ac-Powered | 2 | 2 |
| GAD | Retractor | 2 | 2 |
| HIF | Insufflator, Laparoscopic | 2 | 2 |
| FWZ | Operating Room Accessories Table Tray | 1 | 1 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | 1 |
| KQX | Goniometer, Ac-Powered | 1 | 1 |
Review panels
- General and Plastic Surgery (9)
- General Hospital (3)
- Obstetrics and Gynecology (2)
- Clinical Chemistry (1)
- Neurology (1)
Most recent Andronic Devices, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940812 | INSIGHT ELECTRONIC ALIGNMENT INDICATOR | KQX | 1994-11-21 | 272 |
| K934928 | INSITE FILTER & TUBING SET | HIF | 1994-05-26 | 224 |
| K934926 | INSITE MODEL 20 & MODEL 15 INSUFFLATORS | HIF | 1994-05-26 | 224 |
| K935381 | KAPS POSITIONING ARM | FWZ | 1994-04-15 | 158 |
| K934124 | AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM | JQW | 1994-04-13 | 231 |
| K936308 | ENDEX ENDOSCOPIC POSITIONING SYSTEM | FQO | 1994-03-31 | 101 |
| K932253 | ARTHROBOT BI-FOLD DRAPE | KKX | 1994-02-03 | 269 |
| K922626 | ADEPT INSTRUMENT POSITIONING ACCESSORY | GAD | 1992-10-19 | 138 |
| K922625 | ADEPT ENDOSCOPIC POSITIONER | GAD | 1992-10-19 | 138 |
| K911521 | ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP | KKX | 1991-08-02 | 120 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Andronic Devices, Ltd..
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 Andronic Devices, Ltd.?
FDA lists 16 510(k) clearances under the applicant name “Andronic Devices, Ltd.” (first 1987, latest 1994), across 8 product codes in 5 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 Andronic Devices, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Andronic Devices, Ltd. is 129 days.
Which FDA product codes appear under Andronic Devices, Ltd.?
The most frequent FDA product codes under this applicant name are JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered, 4); KKX (Drape, Surgical, Antimicrobial, 3); FQO (Table, Operating-Room, Ac-Powered, 2).
Next steps
- See all 16 Andronic Devices, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JEA, Andronic Devices, Ltd.'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.