Invivo Research Labs, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Invivo Research Labs, Inc.” (first 1980, latest 1987), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
Review panels
- Cardiovascular (4)
- Anesthesiology (1)
Most recent Invivo Research Labs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864730 | INVIVO PULSE OXIMETER, MODEL 4500 | DQA | 1987-05-06 | 153 |
| K864889 | OMNI-TRAK | DSB | 1987-03-06 | 84 |
| K833978 | OMEGA 5000 | DXN | 1984-03-09 | 113 |
| K810838 | NEONATAL BLOOD PRESSURE CUFF | DXQ | 1981-04-03 | 7 |
| K800066 | NIASTAT | DXN | 1980-02-29 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Invivo Research Labs, 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 Research, Inc. (14 510(k)s)
- Invivo Corporation (Business Trade Name: Philips) (6 510(k)s)
- Invivo Therapeutics Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Invivo Research Labs, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Invivo Research Labs, Inc.” (first 1980, latest 1987), 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 Invivo Research Labs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Invivo Research Labs, Inc. is 84 days.
Which FDA product codes appear under Invivo Research Labs, Inc.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); DQA (Oximeter, 1); DSB (Plethysmograph, Impedance, 1).
Next steps
- See all 5 Invivo Research Labs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Invivo Research Labs, 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.