510(k) · Cleared
ClearedFalck Applanation Tonometer (FAT2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Falck Medical, Inc. · HKY Tonometer, Manual
Cleared on Jun 3, 2008 as substantially equivalent to K981432 (Golden Vision, Inc., 1999) and 1 other predicate after a 341-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Jun 3, 2008
- Review
- 341 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981432 (1999). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K151491Falck Medical Multifunction Tonometer, FAT1Falck Medical, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981432 | Goldman Manual Tonometer | Golden Vision, Inc. | 1999 | — |
| 0 (this device) | K071755 | Falck Applanation Tonometer (FAT2) | Falck Medical, Inc. | 2008 | — |
| +1 | K151491 | Falck Medical Multifunction Tonometer, FAT1 | Falck Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HKY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HKY device
- #1 K241447 iCare ST500 (TA04)score 9.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981432 | Goldman Manual TonometerSummary page 1…3. Substantial Equivalence: The Faick Applanation Tonometer Model 2 (FAT 2) is substantially equivalent to the Goldmann Applanation Tonometer SL 900, (K981432). The device is based on the Imbert - Fick Law and uses applanation of the cornea to measure the intraocular pressure. A… | 1999 |
| * | K010998 | Langham Ocular Blood Flow (Obf) Tonograph/Tonometer Model 201Summary page 1…pplanation of the cornea to measure the intraocular pressure. Additionally, the FAT 2 is substantially equivalent to the Langhamn Model 201 Tonograph/Tonometer (K010998) for the measurement of ocular pulsatile amplitude. The list of equivalent devices follows: K981432 /12/1999,… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151491 | Falck Medical Multifunction Tonometer, FAT1 | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HKY devicesHKY Tonometer, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HKY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HKY
128in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKY
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKY
1in 2019
MAUDE reports naming product code HKY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 3 | 123 | 2 | 3 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 3 | 226 | 0 | 2 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 77 | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 128 | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Falck Medical Applanation Tonometer Model 2 (FAT 2) is indicated in the measurement of intraocular pressure and ocular pulsatile amplitude.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071755: Falck Applanation Tonometer (FAT2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071755
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026