Cpac, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cpac, Inc.” (first 1977, latest 2011), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| KMH | Sterilizer, Dry Heat | 2 | 2 |
| EHZ | Evacuator, Oral Cavity | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 | 1 |
Review panels
Most recent Cpac, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110867 | STERI-DENT, STERI-SURE | FRG | 2011-07-20 | 113 |
| K094026 | STERI-DENT, STERI-SURE | KMH | 2011-07-12 | 559 |
| K781486 | STERI-VAC POWER UNITS | EHZ | 1978-09-27 | 30 |
| K771071 | PORTO-VAC | JCX | 1977-07-14 | 30 |
| K771070 | DRY HEAT STERILIZER | KMH | 1977-07-14 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Cpac, 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 Cpac, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Cpac, Inc.” (first 1977, latest 2011), across 4 product codes in 3 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 Cpac, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cpac, Inc. is 30 days.
Which FDA product codes appear under Cpac, Inc.?
The most frequent FDA product codes under this applicant name are KMH (Sterilizer, Dry Heat, 2); EHZ (Evacuator, Oral Cavity, 1); FRG (Wrap, Sterilization, 1).
Next steps
- See all 5 Cpac, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KMH, Cpac, 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.