Jelco Laboratories: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Jelco Laboratories” (first 1976, latest 1979), across 13 product codes in 5 review panels. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 5 | 5 |
| FPA | Set, Administration, Intravascular | 4 | 4 |
| FPB | Filter, Infusion Line | 4 | 4 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 3 | 3 |
| GAA | Needle, Aspiration And Injection, Disposable | 2 | 2 |
| BSN | Filter, Conduction, Anesthetic | 1 | 1 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| FRL | Fiber, Medical, Absorbent | 1 | 1 |
| GBJ | Prosthesis, Adhesive, External | 1 | 1 |
Plus 3 more product codes.
Review panels
- General Hospital (15)
- General and Plastic Surgery (5)
- Clinical Chemistry (3)
- Anesthesiology (2)
- Cardiovascular (1)
Most recent Jelco Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791918 | JELCO WINGED INTRAVASCULAR CATHETER | FOZ | 1979-10-02 | 7 |
| K791372 | JELCO & KVO CATHETER PLACEMENT UNIT | JCY | 1979-09-12 | 50 |
| K790967 | CATHETER METAL HUB/RADIOPAQUE | FOZ | 1979-06-27 | 36 |
| K790968 | CATHETER METAL HUB/NONRADIOPAQUE | FOZ | 1979-06-11 | 20 |
| K790471 | JELCO* DISC FILTER-0.2 MICRON | FPB | 1979-04-30 | 56 |
| K790186 | PROTECTIVSTABILIZER | GBJ | 1979-02-26 | 28 |
| K790107 | CATHETER TUBING MODIFICATION | DQO | 1979-02-01 | 16 |
| K790079 | NEEDLE, BLOOD COLLECTING | GAA | 1979-02-01 | 23 |
| K781857 | TRAY, ARTERIAL BLOOD GAS SAMPLING | CBT | 1978-12-11 | 35 |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | GCB | 1978-08-23 | 85 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jelco 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 Jelco Laboratories (a text match, not an official crosswalk):
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via JCY)
- L8608 — Miscellaneous external component, supply or accessory for use with the argus ii retinal prosthesis system (via GBJ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via JCY)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jelco Laboratories?
FDA lists 26 510(k) clearances under the applicant name “Jelco Laboratories” (first 1976, latest 1979), across 13 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 Jelco Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jelco Laboratories is 38 days.
Which FDA product codes appear under Jelco Laboratories?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 5); FPA (Set, Administration, Intravascular, 4); FPB (Filter, Infusion Line, 4).
Next steps
- See all 26 Jelco Laboratories clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Jelco 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.