Travenol Laboratories, S.A.: FDA clearances and approvals
Travenol Laboratories, S.A. has 206 FDA 510(k) clearances (first 1976, latest 1988), across 78 product codes in 12 review panels. Median 510(k) review time: 42 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 23 | 23 |
| FPA | Set, Administration, Intravascular | 21 | 21 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 12 | 12 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 9 | 9 |
| CAF | Nebulizer (Direct Patient Interface) | 8 | 8 |
| FKX | System, Peritoneal, Automatic Delivery | 8 | 8 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 8 | 8 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 5 | 5 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 5 | 5 |
| KGO | Surgeon'S Gloves | 5 | 5 |
Plus 68 more product codes.
Review panels
- General Hospital (76)
- Gastroenterology and Urology (68)
- Anesthesiology (25)
- Cardiovascular (9)
- Hematology (8)
- Clinical Chemistry (7)
- General and Plastic Surgery (4)
- Clinical Toxicology (3)
- Pathology (2)
- Dental (1)
- Immunology (1)
- Physical Medicine (1)
Most recent Travenol Laboratories, S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874181 | BAXTER BEDSIDE SYSTEM | FRN | 1988-02-22 | 131 |
| K873894 | CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE | FPA | 1987-11-05 | 42 |
| K873873 | RESUBMITTED MICRON TRANSFUSION FILTER | CAK | 1987-10-22 | 52 |
| K873984 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) | KDJ | 1987-10-20 | 20 |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | FII | 1987-10-13 | 117 |
| K872652 | UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM | FKX | 1987-09-30 | 85 |
| K870801 | FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD | FRN | 1987-09-04 | 189 |
| K871908 | IV ADMINISTRATION SET | BRZ | 1987-07-27 | 73 |
| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | FJI | 1987-06-12 | 59 |
| K865029 | CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER | FPB | 1987-04-17 | 115 |
196 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Travenol Laboratories, S.A..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Travenol Laboratories, S.A.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via JCY)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via JCY)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Frequently asked questions
How many FDA 510(k) clearances does Travenol Laboratories, S.A. have?
Travenol Laboratories, S.A. has 206 FDA 510(k) clearances (first 1976, latest 1988), across 78 product codes in 12 review panels.
How long does FDA take to clear Travenol Laboratories, S.A.'s 510(k)s?
The median time from FDA receipt to decision across Travenol Laboratories, S.A.'s cleared 510(k)s is 42 days.
What devices does Travenol Laboratories, S.A. make?
Its most frequent FDA product codes are FRN (Pump, Infusion, 23); FPA (Set, Administration, Intravascular, 21); KDJ (Set, Administration, For Peritoneal Dialysis, Disposable, 12).
Has Travenol Laboratories, S.A. had device recalls?
openFDA lists no recalls under a recalling firm name matching Travenol Laboratories, S.A. Related entities may recall under other names.
Next steps
- See all 206 Travenol Laboratories, S.A. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Travenol Laboratories, S.A.'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.