Vasomedical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Vasomedical, Inc.” (first 2000, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 4 | 4 |
| DRN | Device, Counter-Pulsating, External | 3 | 3 |
Review panels
- Cardiovascular (7)
Most recent Vasomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111180 | VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY | DSH | 2011-06-28 | 62 |
| K111096 | VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY | DSH | 2011-06-24 | 65 |
| K092785 | COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 | DSH | 2010-04-02 | 204 |
| K083820 | VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C | DSH | 2009-04-01 | 100 |
| K033617 | EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY | DRN | 2004-03-01 | 104 |
| K020857 | EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER | DRN | 2002-06-14 | 88 |
| K003469 | EECP THERAPY SYSTEM, MODEL TS3 | DRN | 2000-12-06 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Vasomedical, 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 Vasomedical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Vasomedical, Inc.” (first 2000, latest 2011), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vasomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vasomedical, Inc. is 88 days.
Which FDA product codes appear under Vasomedical, Inc.?
The most frequent FDA product codes under this applicant name are DSH (Recorder, Magnetic Tape, Medical, 4); DRN (Device, Counter-Pulsating, External, 3).
Next steps
- See all 7 Vasomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSH, Vasomedical, 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.