Jedmed Instrument Co.: FDA clearances and approvals
Jedmed Instrument Co. has 92 FDA 510(k) clearances (first 1979, latest 2014), across 49 product codes in 12 review panels. Median 510(k) review time: 58 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 234 |
| 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 |
|---|---|---|---|
| ETF | Unit, Examining/Treatment, Ent | 17 | 17 |
| DZI | Drill, Bone, Powered | 4 | 4 |
| ERA | Otoscope | 4 | 4 |
| ETP | Stimulator, Caloric-Water | 4 | 4 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 4 | 4 |
| FWD | Camera, Television, Microsurgical, Without Audio | 4 | 4 |
| EQH | Source, Carrier, Fiberoptic Light | 3 | 3 |
| HOZ | Sponge, Ophthalmic | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 | 2 |
Plus 39 more product codes.
Review panels
- Ear, Nose and Throat (40)
- Ophthalmic (17)
- General and Plastic Surgery (15)
- Dental (4)
- General Hospital (3)
- Radiology (3)
- Cardiovascular (2)
- Obstetrics and Gynecology (2)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- Microbiology (1)
- Neurology (1)
Most recent Jedmed Instrument Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132039 | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | EQN | 2014-02-21 | 234 |
| K021750 | LID CHAIN EYELID WEIGHTS | MML | 2003-01-27 | 244 |
| K954184 | JED-LIGHT FIBEROPTIC LIGHT SOURCE | EQH | 1995-11-13 | 68 |
| K944032 | VIDEO SCOPE SYSTEM (LARYNGOSCOPE) | ENZ | 1995-09-15 | 394 |
| K953457 | JEDMED SPECTRUM ENT CABINET | ETF | 1995-08-11 | 21 |
| K950925 | JEDMED LARYNGEAL SCOPE | EOQ | 1995-08-11 | 163 |
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | KHH | 1995-06-28 | 127 |
| K950078 | MICROFLOW IRRIGATION SYSTEM | KMA | 1995-06-21 | 162 |
| K944671 | VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) | EOB | 1995-02-07 | 138 |
| K944031 | VIDEO SCOPE SYSTEM (OTOSCOPE) | ERA | 1994-09-23 | 37 |
82 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jedmed Instrument Co..
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 Jedmed Instrument Co. have?
Jedmed Instrument Co. has 92 FDA 510(k) clearances (first 1979, latest 2014), across 49 product codes in 12 review panels.
How long does FDA take to clear Jedmed Instrument Co.'s 510(k)s?
The median time from FDA receipt to decision across Jedmed Instrument Co.'s cleared 510(k)s is 58 days.
What devices does Jedmed Instrument Co. make?
Its most frequent FDA product codes are ETF (Unit, Examining/Treatment, Ent, 17); DZI (Drill, Bone, Powered, 4); ERA (Otoscope, 4).
Has Jedmed Instrument Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jedmed Instrument Co. Related entities may recall under other names.
Next steps
- See all 92 Jedmed Instrument Co. clearances with predicates and recalls
- Run predicate analysis for product code ETF, Jedmed Instrument Co.'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.