Medical device manufacturer
Kelleher Corp.
Kelleher Corp. holds 94 FDA 510(k) clearances across 69 product codes. Median elapsed review time is 29 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 94
- Product codes
- 69
- Median review
- 29 days
- Recall records
- 0
How does FDA spell Kelleher Corp.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Kelleher Corp. file in?
69 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EQN | Laryngoscope, Nasopharyngoscope | 6 | 16 days | |
| KTG | Knife, Ent | 5 | 32 days | |
| EQH | Source, Carrier, Fiberoptic Light | 4 | 28 days | |
| GBB | Chair, Surgical, Ac-Powered | 3 | 29 days | |
| EOQ | Bronchoscope (Flexible Or Rigid) | 2 | 28 days | |
| EPT | Microscope, Surgical | 2 | 22 days | |
| ETF | Unit, Examining/Treatment, Ent | 2 | 68 days | |
| FSO | Microscope, Surgical, General & Plastic Surgery | 2 | 22 days | |
| GWN | Nystagmograph | 2 | 18 days | |
| JEK | Forceps, Biopsy, Bronchoscope (Rigid) | 2 | 32 days | |
| JYG | Curette, Ear | 2 | 32 days | |
| JYL | Hook, Microsurgical Ear | 2 | 28 days | |
| KAD | Elevator, Ent | 2 | 18 days | |
| KAI | Mirror, Ent | 2 | 28 days | |
| EBA | Light, Surgical Headlight | 1 | 61 days | |
| EKL | Point, Silver, Endodontic | 1 | 21 days | |
| EPY | Speculum, Ent | 1 | 19 days | |
| EQL | Laryngostroboscope | 1 | 17 days | |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 35 days | |
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 | 19 days | |
| ETD | Tube, Tympanostomy | 1 | 111 days | |
| ETY | Tester, Auditory Impedance | 1 | 21 days | |
| EWC | Chamber, Acoustic (For Audiometric Testing) | 1 | 42 days | |
| FFZ | Cord, Electric, For Endoscope | 1 | 22 days | |
| FGS | Carrier, Sponge, Endoscopic | 1 | 35 days |
Showing the 25 they file in most, of 69.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Kelleher Corp. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Kelleher Corp. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K822618 | EMERGENCY TRACHEOSTOMY INSTRUMENT SET | LJW | 148 | |
| K822268 | NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH | GWN | 183 | |
| K823083 | ELECTROSURGICAL UNIT | GEI | 49 | |
| K823111 | NYSTYMOGRAPH ACCESS | GNN | 28 | |
| K822252 | ENT TREATMENT UNITS | ETF | 116 | |
| K822272 | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | HPQ | 104 | |
| K822017 | TYMPANOSTOMY TUBES & VARIOUS TYPES | ETD | 111 | |
| K822257 | VARIOUS TYPES OF LIGHT SOURCE HANDLES | EOQ | 89 | |
| K822259 | LARYNGEAL SPATULAS | EQH | 85 | |
| K822004 | FACE SHIELDS | KNT | 104 |
Source: openFDA device/510k · retrieved
Watch what Kelleher Corp. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.