Novacon Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Novacon Corp.” (first 1994, latest 1999), across 1 product code in 1 review panel. Median 510(k) review time under this name: 175 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 |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Novacon Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992015 | FREEDOM INFUSION SYSTEM | MEB | 1999-09-10 | 87 |
| K960318 | DIB INFUSOR-RA | MEB | 1996-08-05 | 195 |
| K955849 | DIB INFUSOR | MEB | 1996-08-05 | 222 |
| K944665 | DIB INFUSORS | MEB | 1995-02-14 | 155 |
| K941766 | DIB INFUSOR | MEB | 1994-08-05 | 116 |
| K930404 | DIB INFUSOR | MEB | 1994-02-25 | 395 |
Recalls
openFDA lists no recalls under a recalling firm named Novacon Corp..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Novacon Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
Frequently asked questions
How many FDA 510(k) clearances are listed under Novacon Corp.?
FDA lists 6 510(k) clearances under the applicant name “Novacon Corp.” (first 1994, latest 1999), across 1 product code 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 Novacon Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novacon Corp. is 175 days.
Which FDA product codes appear under Novacon Corp.?
The most frequent FDA product codes under this applicant name are MEB (Pump, Infusion, Elastomeric, 6).
Next steps
- See all 6 Novacon Corp. clearances with predicates and recalls
- Run predicate analysis for product code MEB, Novacon Corp.'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.