Invivo Research, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Invivo Research, Inc.” (first 1989, latest 2005), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 224 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Philips, based on public ownership records.
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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 4 | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
| MLD | Monitor, St Segment With Alarm | 1 | 1 |
Review panels
- Cardiovascular (13)
- Anesthesiology (1)
Most recent Invivo Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050399 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 | MWI | 2005-08-26 | 191 |
| K043354 | MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 | DRT | 2005-01-10 | 35 |
| K041918 | INTEGRATED PATIENT MONITORING SYSTEM | MWI | 2004-10-15 | 91 |
| K040915 | MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M | MWI | 2004-09-22 | 167 |
| K002604 | CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM | DSI | 2002-02-07 | 534 |
| K002030 | OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES | MWI | 2000-09-26 | 85 |
| K980045 | CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM | DSI | 1998-11-16 | 314 |
| K974581 | MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT | DRT | 1998-10-28 | 324 |
| K971840 | OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM | MHX | 1998-03-04 | 289 |
| K955045 | OMNI-TRAK PATIENT MONITORING SYSTEM | DPS | 1996-07-11 | 251 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Invivo Research, 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.
- Invivo Corporation (39 510(k)s)
- Invivo Corporation (Business Trade Name: Philips) (6 510(k)s)
- Invivo Research Labs, Inc. (5 510(k)s)
- Invivo Therapeutics Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Invivo Research, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Invivo Research, Inc.” (first 1989, latest 2005), across 8 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 Invivo Research, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Invivo Research, Inc. is 224 days.
Which FDA product codes appear under Invivo Research, Inc.?
The most frequent FDA product codes under this applicant name are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 4); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 3); DSI (Detector And Alarm, Arrhythmia, 2).
Next steps
- See all 14 Invivo Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MWI, Invivo Research, 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.