Non-Invasive Monitoring Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Non-Invasive Monitoring Systems, Inc.” (first 1989, latest 2001), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 227 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 4 | 4 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 1 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
Review panels
- Cardiovascular (4)
- Anesthesiology (2)
Most recent Non-Invasive Monitoring Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012020 | RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC | DQK | 2001-08-21 | 54 |
| K001369 | RESPIEVENTS, VERSION 4.2 | DQK | 2000-07-26 | 86 |
| K942852 | RESPITRACE PT | DQK | 1996-02-13 | 610 |
| K942771 | RESPIEVENTS | DQK | 1996-02-13 | 610 |
| K903011 | RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL | BZQ | 1991-03-29 | 263 |
| K884959 | RESPITRAK | BZK | 1989-06-08 | 191 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-05-07.
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 Non-Invasive Monitoring Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Non-Invasive Monitoring Systems, Inc.” (first 1989, latest 2001), across 3 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 Non-Invasive Monitoring Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Non-Invasive Monitoring Systems, Inc. is 227 days.
Which FDA product codes appear under Non-Invasive Monitoring Systems, Inc.?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 4); BZK (Spirometer, Monitoring (W/Wo Alarm), 1); BZQ (Monitor, Breathing Frequency, 1).
Next steps
- See all 6 Non-Invasive Monitoring Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQK, Non-Invasive Monitoring Systems, 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.