FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K Number: K053430
·
Decision Mar 3, 2006
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
37
Review Days
84
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
- K Number
- K053430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Xomed, Inc.
- Date Received
- December 9, 2005
- Decision Date
- March 3, 2006
- Product Code
- HKY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HKY | Tonometer, Manual | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKY), ordered by most recent decision date.
iCare ST500 (TA04)
FDA 510(k)
FDA Class 2
·Ophthalmic
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
FDA 510(k)
FDA Class 2
·Ophthalmic
CATS-L Tonometer Prism
FDA 510(k)
FDA Class 2
·Ophthalmic
Applanation Tonometer HT-5000
FDA 510(k)
FDA Class 2
·Ophthalmic
iCare IC200
FDA 510(k)
FDA Class 2
·Ophthalmic
iCare HOME2
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Medtronic Xomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | Feb 10, 2026 | Substantially Equivalent |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Oct 26, 2023 | Substantially Equivalent |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Aug 30, 2023 | Substantially Equivalent |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | Mar 21, 2022 | Substantially Equivalent |
| K210841 | NuVent Eustachian Tube Dilation Balloon | Aug 16, 2021 | Substantially Equivalent |
| K200759 | NIM Vital, Nerve Integrity Monitor | Oct 28, 2020 | Substantially Equivalent |
| K173855 | Sharpsite AC Rigid Endsocope | Apr 20, 2018 | Substantially Equivalent |
| K152121 | NuVent EM Sinus Dilation System | Dec 1, 2015 | Substantially Equivalent |
| K151758 | ALAR Nasal Valve Stent | Oct 29, 2015 | Substantially Equivalent |
| K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | Aug 14, 2015 | Substantially Equivalent |