Teleflex Medical: FDA clearances and approvals
Teleflex Medical has 41 FDA 510(k) clearances (first 2003, latest 2026), plus 1 PMA decision, across 23 product codes in 6 review panels. Median 510(k) review time: 69 days. Since 2017 its median was 102 days, against 125 days for all cleared 510(k)s in the same product codes. openFDA lists 303 product recalls by a recalling firm named Teleflex Medical.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 352 |
| 2013 | 3 | 93 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 166 |
| 2017 | 0 | — |
| 2018 | 4 | 128 |
| 2019 | 1 | 226 |
| 2020 | 2 | 146 |
| 2021 | 1 | 203 |
| 2022 | 1 | 31 |
| 2023 | 3 | 65 |
| 2024 | 3 | 113 |
| 2025 | 3 | 120 |
| 2026 | 2 | 42 |
Review time against the same product codes
Since 2017, Teleflex Medical's cleared 510(k)s took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FZP | Clip, Implantable | 7 | 7 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 6 | 6 |
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 3 | 3 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
| EZC | Catheter, Coude | 2 | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
Plus 13 more product codes.
Review panels
- General and Plastic Surgery (20)
- Anesthesiology (11)
- General Hospital (4)
- Cardiovascular (3)
- Gastroenterology and Urology (3)
- Orthopedic (1)
Most recent Teleflex Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | NEW | 2026-07-09 | 27 |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape | GAT | 2026-05-06 | 57 |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating Clips | FZP | 2025-07-03 | 90 |
| K242495 | LMA Fastrach ETT SU | BTR | 2025-04-29 | 250 |
| K243553 | QuikClot Control+ Hemostatic Device | POD | 2025-03-18 | 120 |
| K241784 | Arrow® Nitinol Wire | DQX | 2024-09-18 | 90 |
| K233713 | Pilling Tracheostomy Tubes | BTO | 2024-03-22 | 123 |
| K232970 | Hem-o-lok® Ligating Clips | FZP | 2024-01-12 | 113 |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) | BSO | 2023-08-30 | 180 |
| K231924 | EZ-IO Intraosseous Vascular Access System | FMI | 2023-07-25 | 25 |
31 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180025 | PMA | MANTA Vascular Closure Device | 2019-02-01 |
Recalls
303 product recalls in 120 recall events; 9 initiated in the last five years. Most recent: 2022-04-11.
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 Teleflex Medical have?
Teleflex Medical has 41 FDA 510(k) clearances (first 2003, latest 2026), plus 1 PMA decision, across 23 product codes in 6 review panels.
How long does FDA take to clear Teleflex Medical's 510(k)s?
The median time from FDA receipt to decision across Teleflex Medical's cleared 510(k)s is 69 days. Since 2017: 102 days, versus 125 days for all cleared 510(k)s in the same product codes.
What devices does Teleflex Medical make?
Its most frequent FDA product codes are FZP (Clip, Implantable, 7); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 6); FMI (Needle, Hypodermic, Single Lumen, 3).
Has Teleflex Medical had device recalls?
openFDA lists 303 product recalls in 120 recall events by a recalling firm whose name matches Teleflex Medical; the most recent began 2022-04-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 41 Teleflex Medical clearances with predicates and recalls
- Run predicate analysis for product code FZP, Teleflex Medical'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.