Rusch, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Rusch, Inc.” (first 1993, latest 2001), across 13 product codes in 3 review panels. Median 510(k) review time under this name: 145 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Teleflex, based on public ownership records.
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) | 10 | 10 |
| EZL | Catheter, Retention Type, Balloon | 2 | 2 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| KOB | Catheter, Suprapubic (And Accessories) | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| BSR | Stylet, Tracheal Tube | 1 | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BTS | Tube, Bronchial (W/Wo Connector) | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Rusch, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010420 | RUSCH MMG/O'NEIL CATHETER | FCM | 2001-05-09 | 86 |
| K993528 | RUSCH EMERGENCY MASK | CBP | 2000-05-31 | 226 |
| K993194 | RUSCH MANUAL RESUSCITATOR BAG | BTM | 2000-03-24 | 183 |
| K980870 | RUSCH SILICONE FOLEY CATHETER | EZL | 1998-06-09 | 97 |
| K974419 | RUSCH SIMPLASTIC COUNCILL TIP CATHETER | EZL | 1998-01-27 | 64 |
| K963779 | RUSCH ENTERAL FEEDING TUBE | FPD | 1997-05-23 | 245 |
| K970021 | RUSCH SUPRAPUBIC TRAY | KOB | 1997-02-07 | 35 |
| K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | FCM | 1996-12-17 | 74 |
| K955564 | RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE | JOH | 1996-06-28 | 205 |
| K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE | BTR | 1996-06-27 | 209 |
16 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-02-03.
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.
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.
- Rusch Intl. (43 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rusch, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Rusch, Inc.” (first 1993, latest 2001), across 13 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 Rusch, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rusch, Inc. is 145 days.
Which FDA product codes appear under Rusch, Inc.?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 10); EZL (Catheter, Retention Type, Balloon, 2); FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 2).
Next steps
- See all 26 Rusch, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTR, Rusch, 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.