Neoforce Group, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Neoforce Group, Inc.” (first 2006, latest 2011), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 106 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 2 | 2 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| FMZ | Incubator, Neonatal | 1 | 1 |
Review panels
- Anesthesiology (6)
- General Hospital (1)
Most recent Neoforce Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110119 | PRESSURE MANOMETER | CAP | 2011-06-10 | 143 |
| K103833 | NEOPIP PATIENT CIRCUIT WITH PEEP | BYE | 2011-04-20 | 111 |
| K102649 | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | BTM | 2011-01-06 | 114 |
| K092085 | ISPIRA RESUSCITATION UNIT | BTL | 2009-10-07 | 90 |
| K072021 | NEOPIP INFANT RESUSCITATOR | BTM | 2007-09-12 | 51 |
| K070416 | NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP | BYE | 2007-05-29 | 106 |
| K061280 | V-2200 INFANT INCUBATOR | FMZ | 2006-06-27 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Neoforce Group, 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 Neoforce Group, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Neoforce Group, Inc.” (first 2006, latest 2011), across 5 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 Neoforce Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neoforce Group, Inc. is 106 days.
Which FDA product codes appear under Neoforce Group, Inc.?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 2); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 2); BTL (Ventilator, Emergency, Powered (Resuscitator), 1).
Next steps
- See all 7 Neoforce Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Neoforce Group, 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.