Andromed, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Andromed, Inc.” (first 2000, latest 2005), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 91 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 |
|---|---|---|---|
| DQD | Stethoscope, Electronic | 4 | 4 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
Review panels
- Cardiovascular (4)
- Anesthesiology (1)
Most recent Andromed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051779 | ANDROFLOW - RESPIRATORY RATE MONITOR | BZQ | 2005-09-30 | 91 |
| K022298 | I-STETHOS LINK | DQD | 2002-10-01 | 77 |
| K021389 | BIOLOGICAL SOUND MONITOR (BSM) SENSOR | DQD | 2002-10-01 | 152 |
| K010729 | AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A | DQD | 2001-10-26 | 228 |
| K001306 | STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX | DQD | 2000-07-20 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Andromed, 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 Andromed, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Andromed, Inc.” (first 2000, latest 2005), 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 Andromed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Andromed, Inc. is 91 days.
Which FDA product codes appear under Andromed, Inc.?
The most frequent FDA product codes under this applicant name are DQD (Stethoscope, Electronic, 4); BZQ (Monitor, Breathing Frequency, 1).
Next steps
- See all 5 Andromed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQD, Andromed, 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.