Hyland Therapeutic Div., Travenol Laboratories: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Hyland Therapeutic Div., Travenol Laboratories” (first 1976, latest 1982), across 37 product codes in 5 review panels. Median 510(k) review time under this name: 44 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 3 | 3 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 | 2 |
| DIF | Drug Mixture Control Materials | 2 | 2 |
| GFO | Activated Partial Thromboplastin | 2 | 2 |
| LGO | Test, Leukocyte Typing | 2 | 2 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 | 1 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 1 | 1 |
| CZJ | Igd, Antigen, Antiserum, Control | 1 | 1 |
| DBA | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | 1 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
Plus 27 more product codes.
Review panels
- Immunology (18)
- Clinical Chemistry (10)
- Hematology (10)
- Microbiology (2)
- Clinical Toxicology (2)
Most recent Hyland Therapeutic Div., Travenol Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K820835 | ALUMINA SILICA-ACTIVATED PARTIAL THROM | GFO | 1982-04-26 | 31 |
| K820192 | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM | GRP | 1982-03-11 | 45 |
| K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD | JIW | 1981-08-18 | 12 |
| K810078 | Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S | DIF | 1981-02-02 | 20 |
| K810077 | OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. | DIF | 1981-01-28 | 15 |
| K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | DER | 1981-01-05 | 76 |
| K791113 | LOW IONIC STRENGTH SOLUTION (LISS) | KSG | 1979-06-28 | 13 |
| K790249 | TEST CELLS | KSF | 1979-05-16 | 97 |
| K781225 | GLOBULIN TEST, HUMAN THYROXINE BINDING | CEE | 1978-08-31 | 44 |
| K780962 | AUTOMATED ENZYME | KSK | 1978-07-27 | 45 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hyland Therapeutic Div., Travenol Laboratories.
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 Hyland Therapeutic Div., Travenol Laboratories (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Hyland Therapeutic Div., Travenol Laboratories?
FDA lists 44 510(k) clearances under the applicant name “Hyland Therapeutic Div., Travenol Laboratories” (first 1976, latest 1982), across 37 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 Hyland Therapeutic Div., Travenol Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hyland Therapeutic Div., Travenol Laboratories is 44 days.
Which FDA product codes appear under Hyland Therapeutic Div., Travenol Laboratories?
The most frequent FDA product codes under this applicant name are JIX (Calibrator, Multi-Analyte Mixture, 3); DAK (Complement C1q, Antigen, Antiserum, Control, 2); DIF (Drug Mixture Control Materials, 2).
Next steps
- See all 44 Hyland Therapeutic Div., Travenol Laboratories clearances with predicates and recalls
- Run predicate analysis for product code JIX, Hyland Therapeutic Div., Travenol Laboratories'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.