Inviro Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Inviro Medical Devices, Inc.” (first 2007, latest 2010), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| MEG | Syringe, Antistick | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Inviro Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101359 | INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) | FMF | 2010-08-20 | 98 |
| K092430 | 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES | MEG | 2009-09-04 | 28 |
| K092413 | INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES | MEG | 2009-09-04 | 28 |
| K083851 | INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 | LHI | 2009-05-15 | 142 |
| K081436 | INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES | FMF | 2008-10-22 | 154 |
| K071307 | INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 | FMI | 2008-02-12 | 279 |
| K070203 | INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024 | MEG | 2007-04-23 | 91 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-05-10.
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.
- Inviro Medical (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inviro Medical Devices, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Inviro Medical Devices, Inc.” (first 2007, latest 2010), across 4 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 Inviro Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inviro Medical Devices, Inc. is 98 days.
Which FDA product codes appear under Inviro Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are MEG (Syringe, Antistick, 3); FMF (Syringe, Piston, 2); FMI (Needle, Hypodermic, Single Lumen, 1).
Next steps
- See all 7 Inviro Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MEG, Inviro Medical Devices, 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.