510(k) · Cleared
ClearedKeeler Pulsair 3000 Non Contact Tonometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keeler Instruments, Inc. · HKX Tonometer, Ac-Powered
Cleared on Mar 25, 1999 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Mar 25, 1999
- Review
- 57 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK990257 Keeler Pulsair 3000 Non Contact TonometerKeeler Instruments, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK093298 Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000Keeler Instruments, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK143086 VX120 Ophthalmic Diagnostic DeviceLuneau Sas · 2015
- Descendant · 3 generations on · 1 of its ownK162067 VX130 Ophthalmic Diagnostic DeviceLuneau Sas · 2017
- Descendant · 4 generations on · 0 of its ownK202221 VX650Luneau Technology Operations · 2021
- Descendant · 3 generations on · 0 of its ownK201724 Pentacam AXL WaveOculus Optikgerate GmbH · 2020 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K093298Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000Keeler Instruments, Inc. · 2010 · cites it directly5descendants
- K143086VX120 Ophthalmic Diagnostic DeviceLuneau Sas · 2015 · 2 generations on3descendants
- K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas · 2017 · 3 generations on1descendant
- K202221VX650Luneau Technology Operations · 2021 · 4 generations on0descendants
- K201724Pentacam AXL WaveOculus Optikgerate GmbH · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990257 | Keeler Pulsair 3000 Non Contact Tonometer | Keeler Instruments, Inc. | 1999 | — |
| +1 | K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000 | Keeler Instruments, Inc. | 2010 | — |
| +2 | K143086 | VX120 Ophthalmic Diagnostic Device | Luneau Sas | 2015 | — |
| +3 | K162067 | VX130 Ophthalmic Diagnostic Device | Luneau Sas | 2017 | — |
| +4 | K202221 | VX650 | Luneau Technology Operations | 2021 | — |
| +3 | K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | 2020 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HKX? 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 HKX device
- #1 K253039 Auto Kerato-Refracto Tonometer TRK-3 Omniascore 11.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000 | 2010 | 5 |
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?
- Of its descendants, K093298 (Keeler Instruments, Inc., 2010) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HKX devicesHKX Tonometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKX
290in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKX
No recall names HKX since 2007.
Adverse event reports per year · HKX
1in 2015
MAUDE reports naming product code HKX, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 290 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Measurement of the Intraocular Pressure
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990257 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990257: Keeler Pulsair 3000 Non Contact Tonometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990257
Report an extraction error
Are you the manufacturer?
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