Teleflexmedical, Inc.: FDA filings under this applicant name
FDA lists 64 510(k) clearances under the applicant name “Teleflexmedical, Inc.” (first 1985, latest 2024), across 29 product codes in 5 review panels. Median 510(k) review time under this name: 156 days. Since 2017 the median was 189 days, against 127 days for all cleared 510(k)s in the same product codes. 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 | 2 | 66 |
| 2013 | 4 | 98 |
| 2014 | 12 | 217 |
| 2015 | 9 | 190 |
| 2016 | 6 | 203 |
| 2017 | 4 | 176 |
| 2018 | 3 | 151 |
| 2019 | 4 | 205 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 755 |
| 2024 | 1 | 352 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Teleflexmedical, Inc. took a median 189 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 5 | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 4 | 4 |
| DYB | Introducer, Catheter | 4 | 4 |
| EZL | Catheter, Retention Type, Balloon | 4 | 4 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 4 | 4 |
| CAC | Apparatus, Autotransfusion | 3 | 3 |
| CBN | Apparatus, Gas-Scavenging | 3 | 3 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| MSD | Catheter, Hemodialysis, Implanted | 3 | 3 |
Plus 19 more product codes.
Review panels
- Anesthesiology (25)
- General and Plastic Surgery (14)
- Gastroenterology and Urology (13)
- Cardiovascular (11)
- General Hospital (1)
Most recent Teleflexmedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232469 | Rüsch Latex Gold Foley Catheter | EZL | 2024-08-01 | 352 |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | EZL | 2023-07-27 | 755 |
| K192324 | Sheridan Spiral-Flex Endotracheal Tubes | BTR | 2019-12-06 | 101 |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | BWF | 2019-07-01 | 265 |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | KOD | 2019-05-24 | 303 |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | GBM | 2019-05-08 | 145 |
| K181852 | Percuvance Percutaneous Surgical System | GEI | 2018-10-12 | 93 |
| K173280 | Neonatal ConchaSmart Breathing Circuits | BZE | 2018-08-02 | 290 |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | OCW | 2018-02-12 | 151 |
| K161770 | Rusch Silicone Foley Catheter | EZL | 2017-05-05 | 311 |
54 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Teleflexmedical, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Teleflexmedical, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Teleflexmedical, Inc.?
FDA lists 64 510(k) clearances under the applicant name “Teleflexmedical, Inc.” (first 1985, latest 2024), across 29 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 Teleflexmedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Teleflexmedical, Inc. is 156 days. Since 2017: 189 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Teleflexmedical, Inc.?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 5); GCJ (Laparoscope, General & Plastic Surgery, 5); CAF (Nebulizer (Direct Patient Interface), 4).
Next steps
- See all 64 Teleflexmedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTR, Teleflexmedical, 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.