Andros Analyzers, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Andros Analyzers, Inc.” (first 1985, latest 1990), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | 2 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (4)
- Anesthesiology (1)
Most recent Andros Analyzers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903806 | ANGIOTEC IMAGE MANAGEMENT SYSTEM | LMB | 1990-11-23 | 95 |
| K893476 | ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. | JAA | 1989-06-23 | 50 |
| K892869 | ANGIOTEC ZX DIGITAL IMAGE PROCESSOR | LLZ | 1989-05-26 | 37 |
| K891485 | ANGIOTEC FMX-2220 SYSTEM | LMB | 1989-05-05 | 49 |
| K852463 | ANDROS ANALYZERS AIRWAY ADAPTER | CCK | 1985-07-08 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Andros Analyzers, 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.
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.
- Andros Incorporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Andros Analyzers, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Andros Analyzers, Inc.” (first 1985, latest 1990), across 4 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 Andros Analyzers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Andros Analyzers, Inc. is 49 days.
Which FDA product codes appear under Andros Analyzers, Inc.?
The most frequent FDA product codes under this applicant name are LMB (Device, Digital Image Storage, Radiological, 2); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 1); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 1).
Next steps
- See all 5 Andros Analyzers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LMB, Andros Analyzers, 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 (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.