Chrysalis Intelligence · Product Codes · HKY

HKY · Unclassified

9 clearances · 4 unique sponsors

Device class
Regulation —
Total clearances
9
2020-01-14 → 2024-09-27
Last 12 months
0
Unique sponsors
4
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Icare Finland OY 5 0 2024-09-27
Cats Tonometer, LLC 2 0 2024-02-09
Huvitz Co., Ltd. 1 0 2023-10-23
Reichert, Inc. 1 0 2024-05-01
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
92100 CPT High Standard CPT for tonometry measurement
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-09-27 K241447 Icare Finland OY iCare ST500 (TA04)
2024-05-01 K233516 Reichert, Inc. Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
2024-02-09 K234037 Cats Tonometer, LLC CATS-L Tonometer™ Prism
2023-10-23 K232143 Huvitz Co., Ltd. Applanation Tonometer HT-5000
2022-10-06 K220852 Icare Finland OY iCare IC200
2022-01-25 K211355 Icare Finland OY iCare HOME2
2021-06-14 K203850 Cats Tonometer, LLC CATS®-D Tonometer Prism
2020-05-07 K200966 Icare Finland OY Icare HOME Tonometer
2020-01-14 K190316 Icare Finland OY Icare ic200