Rusch Intl.: FDA clearances and approvals
Rusch Intl. has 43 FDA 510(k) clearances (first 1995, latest 2003), across 23 product codes in 3 review panels. Median 510(k) review time: 95 days.
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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 7 | 7 |
| JOH | Tube Tracheostomy And Tube Cuff | 5 | 5 |
| EZL | Catheter, Retention Type, Balloon | 4 | 4 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 | 4 |
| ESW | Prosthesis, Esophageal | 2 | 2 |
| FEN | Device, Cystometric, Hydraulic | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| NYT | Prosthesis, Tracheal, Expandable, Polymeric | 2 | 2 |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 | 1 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
Plus 13 more product codes.
Review panels
Most recent Rusch Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033023 | INTERMITTENT URETHRAL CATHETERS | KOD | 2003-12-23 | 88 |
| K030559 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM | ESW | 2003-06-30 | 129 |
| K023666 | RUSCH GUIDED CHOLANGIOGRAPHY CATHETER | FGE | 2003-06-17 | 229 |
| K023918 | RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS | JOH | 2003-03-28 | 123 |
| K023964 | RUSCH MICROLARYNGEAL TUBE | BTR | 2002-12-23 | 24 |
| K021540 | RUSCH EDGAR TUBE | BTR | 2002-08-01 | 83 |
| K021764 | RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED | BTO | 2002-07-23 | 55 |
| K020714 | RUSCH FLONEIL; FLOCATH INTROGEL | GBM | 2002-07-01 | 118 |
| K010798 | RUSCH CANTOR TUBE | KNT | 2002-02-26 | 347 |
| K010797 | RUSCH MILLER-ABBOTT TUBE | KNT | 2002-02-26 | 347 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rusch Intl..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Rusch Intl. have?
Rusch Intl. has 43 FDA 510(k) clearances (first 1995, latest 2003), across 23 product codes in 3 review panels.
How long does FDA take to clear Rusch Intl.'s 510(k)s?
The median time from FDA receipt to decision across Rusch Intl.'s cleared 510(k)s is 95 days.
What devices does Rusch Intl. make?
Its most frequent FDA product codes are BTR (Tube, Tracheal (W/Wo Connector), 7); JOH (Tube Tracheostomy And Tube Cuff, 5); EZL (Catheter, Retention Type, Balloon, 4).
Has Rusch Intl. had device recalls?
openFDA lists no recalls under a recalling firm name matching Rusch Intl. Related entities may recall under other names.
Next steps
- See all 43 Rusch Intl. clearances with predicates and recalls
- Run predicate analysis for product code BTR, Rusch Intl.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.