Stan-Pak Ent.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Stan-Pak Ent.” (first 1982, latest 1982), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | 9 | 9 |
| EFQ | Gauze/Sponge, Internal | 3 | 3 |
| FQM | Bandage, Elastic | 3 | 3 |
| ITG | Bandage, Cast | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| KEW | Slides, Microscope | 1 | 1 |
| LDQ | 1 | 1 |
Review panels
- General and Plastic Surgery (12)
- General Hospital (3)
- Physical Medicine (2)
- Anesthesiology (1)
- Pathology (1)
Most recent Stan-Pak Ent. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823058 | DOSOMETRIC RELEASE STERILIZATION | EFQ | 1982-12-09 | 52 |
| K820100 | FROSTED GLASS SLIDES | KEW | 1982-03-04 | 50 |
| K820099 | TRACH TAPE | BTO | 1982-02-23 | 41 |
| K820155 | SPECIALIST CAST PADDING | ITG | 1982-02-12 | 24 |
| K820140 | WEBRIL CAST PADDING | ITG | 1982-02-12 | 24 |
| K820108 | TOPPER SPONGES | NAB | 1982-02-12 | 28 |
| K820107 | GUAZE SPONGES, PLAIN | EFQ | 1982-02-12 | 28 |
| K820106 | X-RAY GUAZE SPONGES | EFQ | 1982-02-12 | 28 |
| K820142 | TUBULAR STOCKINETTE | FQM | 1982-02-05 | 17 |
| K820141 | BIAS STOCKINETTE | FQM | 1982-02-05 | 17 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Stan-Pak Ent..
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 Stan-Pak Ent.?
FDA lists 20 510(k) clearances under the applicant name “Stan-Pak Ent.” (first 1982, latest 1982), across 7 product codes in 5 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 Stan-Pak Ent.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stan-Pak Ent. is 24 days.
Which FDA product codes appear under Stan-Pak Ent.?
The most frequent FDA product codes under this applicant name are NAB (Gauze / Sponge,Nonresorbable For External Use, 9); EFQ (Gauze/Sponge, Internal, 3); FQM (Bandage, Elastic, 3).
Next steps
- See all 20 Stan-Pak Ent. clearances with predicates and recalls
- Run predicate analysis for product code NAB, Stan-Pak Ent.'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.