Jayco Pharmaceuticals: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Jayco Pharmaceuticals” (first 1981, latest 1985), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 1 | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| FOG | Hood, Oxygen, Infant | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| KKJ | Sudan Iii | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Jayco Pharmaceuticals 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844691 | ENDOSCOPIC ASPIRATION CATHETER SET | OCX | 1985-01-02 | 30 |
| K844690 | ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT | FCL | 1985-01-02 | 30 |
| K844689 | ENDOSCOPIC MANUAL AIR INSUFFLATOR | FCX | 1985-01-02 | 30 |
| K842009 | ABDOMINAL PARACENTESIS TRAY | FSM | 1984-10-23 | 159 |
| K842001 | LIVER BIOPSY TRAY | — | 1984-10-15 | 152 |
| K841258 | FOREIGN BODY PROTECTOR | FED | 1984-07-09 | 105 |
| K840800 | POLYP-SAVER SLEVE | OCZ | 1984-03-23 | 29 |
| K830781 | ENDO-GUARD | FOG | 1983-03-31 | 20 |
| K810875 | FECAL STAINING KIT | KKJ | 1981-05-01 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Jayco Pharmaceuticals.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Jayco Pharmaceuticals?
FDA lists 9 510(k) clearances under the applicant name “Jayco Pharmaceuticals” (first 1981, latest 1985), across 9 product codes in 4 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 Jayco Pharmaceuticals?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jayco Pharmaceuticals is 30 days.
Which FDA product codes appear under Jayco Pharmaceuticals?
The most frequent FDA product codes under this applicant name are FCL (Forceps, Biopsy, Non-Electric, 1); FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope, 1); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 1).
Next steps
- See all 9 Jayco Pharmaceuticals clearances with predicates and recalls
- Run predicate analysis for product code FCL, Jayco Pharmaceuticals'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.