iCare ST500 (TA04)
FDA 510(k) K241447 · Icare Finland OY
510(k) numberK241447
Submission
- Device name
- iCare ST500 (TA04)
- Applicant
- Icare Finland OY
Vantaa, FI - Received
- May 22, 2024
- Decision date
- September 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HKY – Tonometer, Manual
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
Other 510(k)s with product code HKY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)HKY · Traditional | Reichert, Inc. | 05/01/2024SE |
| K234037 | CATS-L Tonometer PrismHKY · Special | Cats Tonometer, LLC | 02/09/2024SE |
| K232143 | Applanation Tonometer HT-5000HKY · Traditional | Huvitz Co., Ltd. | 10/23/2023SE |
| K220852 | iCare IC200HKY · Traditional | Icare Finland OY | 10/06/2022SE |
| K211355 | iCare HOME2HKY · Traditional | Icare Finland OY | 01/25/2022SE |
| K203850 | CATS®-D Tonometer PrismHKY · Traditional | Cats Tonometer, LLC | 06/14/2021SE |
| K200966 | Icare HOME TonometerHKY · Special | Icare Finland OY | 05/07/2020SE |
| K190316 | Icare ic200HKY · Traditional | Icare Finland OY | 01/14/2020SE |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-QHKY · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 12/19/2019SE |
| K182491 | Applanation tonometer AT-2HKY · Traditional | Takagi Seiko Co., Ltd. | 12/10/2018SE |
More from Takagi Seiko Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K220852 | iCare IC200HKY · Traditional | 10/06/2022SE |
| K211355 | iCare HOME2HKY · Traditional | 01/25/2022SE |
| K200966 | Icare HOME TonometerHKY · Special | 05/07/2020SE |
| K190316 | Icare ic200HKY · Traditional | 01/14/2020SE |
| K163343 | Icare HOME tonometerHKY · Traditional | 03/21/2017SE |
| K153694 | Icare ic100HKY · Traditional | 04/19/2016SE |
Questions and answers
When was iCare ST500 (TA04) cleared by the FDA?
iCare ST500 (TA04) (K241447) received a 510(k) decision of Substantially Equivalent on September 27, 2024, 128 days after the submission was received.
What is the product code of K241447?
The FDA product code is HKY – Tonometer, Manual, a Class II (moderate risk) device regulated under 21 CFR 886.1930.