Ostial Corporation: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Ostial Corporation” (first 2011, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 92 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 | 6 | 76 |
| 2013 | 1 | 78 |
| 2014 | 1 | 195 |
| 2015 | 1 | 30 |
| 2016 | 1 | 169 |
| 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 6 | 6 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 5 | 5 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
Review panels
Most recent Ostial Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152485 | FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm | LOX | 2016-02-16 | 169 |
| K150946 | FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm | LIT | 2015-05-08 | 30 |
| K133861 | FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM | LIT | 2014-07-02 | 195 |
| K131450 | FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 | LOX | 2013-08-06 | 78 |
| K122178 | FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 | LOX | 2012-10-11 | 80 |
| K122379 | FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM | LIT | 2012-09-05 | 30 |
| K121175 | FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM | LIT | 2012-06-29 | 72 |
| K113775 | FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM | LOX | 2012-06-29 | 190 |
| K113582 | ARCHSTENT BILIARY SYSTEM | FGE | 2012-06-29 | 207 |
| K120738 | FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM | LIT | 2012-03-29 | 17 |
2 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-07-14.
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 Ostial Corporation (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ostial Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ostial Corporation?
FDA lists 12 510(k) clearances under the applicant name “Ostial Corporation” (first 2011, latest 2016), across 3 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 Ostial Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ostial Corporation is 92 days.
Which FDA product codes appear under Ostial Corporation?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 6); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 5); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Next steps
- See all 12 Ostial Corporation clearances with predicates and recalls
- Run predicate analysis for product code LIT, Ostial Corporation'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.