Teleflex, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Teleflex, Inc.” (first 1986, latest 2016), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 156 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 | 2 | 280 |
| 2013 | 1 | 57 |
| 2014 | 3 | 203 |
| 2015 | 1 | 436 |
| 2016 | 1 | 183 |
| 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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 3 | 3 |
| CAZ | Anesthesia Conduction Kit | 3 | 3 |
| DYB | Introducer, Catheter | 3 | 3 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
Review panels
- Anesthesiology (7)
- Cardiovascular (3)
Most recent Teleflex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | CAZ | 2016-06-21 | 183 |
| K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET | BSO | 2015-03-27 | 436 |
| K141940 | CONCHASMART COLUMN | BTT | 2014-11-24 | 130 |
| K140556 | CONCHASMART BREATHING CIRCUIT | BTT | 2014-09-24 | 203 |
| K131912 | CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN | BTT | 2014-03-06 | 253 |
| K123974 | PERCUTANEOUS INTRODUCER KIT | DYB | 2013-02-21 | 57 |
| K121403 | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET | CAZ | 2012-06-20 | 41 |
| K103658 | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER | CAZ | 2012-05-16 | 518 |
| K861951 | MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER | DYB | 1986-06-19 | 30 |
| K860307 | PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET | DYB | 1986-05-20 | 112 |
Recalls
151 product recalls in 12 recall events; 140 initiated in the last five years. Most recent: 2026-05-07.
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.
Device clinical trials
An industry sponsor named Teleflex, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06779630: Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (Recruiting, started 2025-07-18)
- NCT06604039: A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices (Recruiting, started 2024-12-08)
- NCT06364865: AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study (Completed, started 2024-06-07)
- NCT02428413: Evaluation and Control of WAG in PACU Within Patient and Caregiver Breathing Zone (Completed, started 2015-04)
SEC filings
TELEFLEX INC (TFX): EDGAR filings, CIK 96943. An SEC registrant with the same name, matched by name only.
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.
- Teleflex Medical (41 510(k)s)
- Teleflex Medical Incorporated (3 510(k)s)
- Teleflex Medical Sdn. Bhd. (3 510(k)s)
- Teleflex Incorporated (1 510(k)s)
- Teleflex Medical Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Teleflex, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Teleflex, Inc.” (first 1986, latest 2016), across 4 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 Teleflex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Teleflex, Inc. is 156 days.
Which FDA product codes appear under Teleflex, Inc.?
The most frequent FDA product codes under this applicant name are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 3); CAZ (Anesthesia Conduction Kit, 3); DYB (Introducer, Catheter, 3).
Next steps
- See all 10 Teleflex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTT, Teleflex, 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.