Octostop, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Octostop, Inc.” (first 1991, latest 1997), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 168 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 8 | 8 |
| KXH | Cradle, Patient, Radiologic | 3 | 3 |
| IXQ | Table, Radiographic, Stationary Top | 1 | 1 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
Review panels
- Radiology (13)
Most recent Octostop, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972766 | PIVOTING COMPENSATING FILTERS FOR THE HEAD | KPR | 1997-08-14 | 21 |
| K963941 | THE PHARAOH COMPENSATING FILTER | KPR | 1996-11-27 | 57 |
| K953246 | OCTOROLL | KXH | 1995-09-29 | 80 |
| K952871 | RIDGES PLUS | KPR | 1995-07-20 | 51 |
| K942916 | OCTOPAQUE UNIVERSAL | IXQ | 1994-09-08 | 79 |
| K940306 | OCTOSTOP COMPENSATING FILTERS | KPR | 1994-09-06 | 237 |
| K935444 | OCTOSTOP(R) CHAIR (NEW MODEL | IXR | 1994-09-02 | 294 |
| K930124 | VARIANT OF OCTOSTOP AND OCTOPAQUE | KXH | 1994-02-09 | 393 |
| K930357 | ACCESSORY TO UNIVERSAL OCTOPAQUE | KXH | 1993-07-13 | 168 |
| K926069 | WRIST TRACTION | KPR | 1993-01-21 | 51 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Octostop, 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 Octostop, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Octostop, Inc.” (first 1991, latest 1997), 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 Octostop, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Octostop, Inc. is 168 days.
Which FDA product codes appear under Octostop, Inc.?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 8); KXH (Cradle, Patient, Radiologic, 3); IXQ (Table, Radiographic, Stationary Top, 1).
Next steps
- See all 13 Octostop, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPR, Octostop, 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.