Kelleher Corp.: FDA clearances and approvals
Kelleher Corp. has 94 FDA 510(k) clearances (first 1982, latest 1983), across 70 product codes in 9 review panels. Median 510(k) review time: 29 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 |
|---|---|---|---|
| EQN | Laryngoscope, Nasopharyngoscope | 6 | 6 |
| KTG | Knife, Ent | 5 | 5 |
| EQH | Source, Carrier, Fiberoptic Light | 4 | 4 |
| GBB | Chair, Surgical, Ac-Powered | 3 | 3 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 2 | 2 |
| EPT | Microscope, Surgical | 2 | 2 |
| ETF | Unit, Examining/Treatment, Ent | 2 | 2 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 2 | 2 |
| GWN | Nystagmograph | 2 | 2 |
| JEK | Forceps, Biopsy, Bronchoscope (Rigid) | 2 | 2 |
Plus 60 more product codes.
Review panels
- Ear, Nose and Throat (60)
- General and Plastic Surgery (17)
- Neurology (6)
- Gastroenterology and Urology (3)
- Dental (2)
- General Hospital (2)
- Microbiology (1)
- Ophthalmic (1)
- Clinical Toxicology (1)
Most recent Kelleher Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K822618 | EMERGENCY TRACHEOSTOMY INSTRUMENT SET | LJW | 1983-01-28 | 148 |
| K822268 | NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH | GWN | 1983-01-28 | 183 |
| K823083 | ELECTROSURGICAL UNIT | GEI | 1982-12-07 | 49 |
| K823111 | NYSTYMOGRAPH ACCESS | GNN | 1982-11-22 | 28 |
| K822252 | ENT TREATMENT UNITS | ETF | 1982-11-22 | 116 |
| K822272 | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | HPQ | 1982-11-10 | 104 |
| K822017 | TYMPANOSTOMY TUBES & VARIOUS TYPES | ETD | 1982-10-27 | 111 |
| K822257 | VARIOUS TYPES OF LIGHT SOURCE HANDLES | EOQ | 1982-10-26 | 89 |
| K822259 | LARYNGEAL SPATULAS | EQH | 1982-10-22 | 85 |
| K822004 | FACE SHIELDS | KNT | 1982-10-20 | 104 |
84 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kelleher Corp..
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 Kelleher Corp. have?
Kelleher Corp. has 94 FDA 510(k) clearances (first 1982, latest 1983), across 70 product codes in 9 review panels.
How long does FDA take to clear Kelleher Corp.'s 510(k)s?
The median time from FDA receipt to decision across Kelleher Corp.'s cleared 510(k)s is 29 days.
What devices does Kelleher Corp. make?
Its most frequent FDA product codes are EQN (Laryngoscope, Nasopharyngoscope, 6); KTG (Knife, Ent, 5); EQH (Source, Carrier, Fiberoptic Light, 4).
Has Kelleher Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kelleher Corp. Related entities may recall under other names.
Next steps
- See all 94 Kelleher Corp. clearances with predicates and recalls
- Run predicate analysis for product code EQN, Kelleher Corp.'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.