510(k) · Cleared
ClearedPulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000
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 Dec 10, 2010 as substantially equivalent to K990257 (Keeler Instruments, Inc., 1999) after a 415-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Dec 10, 2010
- Review
- 415 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990257 (1999). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK990257 Keeler Pulsair 3000 Non Contact TonometerKeeler Instruments, Inc. · 1999
- This deviceK093298 Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000Keeler Instruments, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK143086 VX120 Ophthalmic Diagnostic DeviceLuneau Sas · 2015
- Descendant · 2 generations on · 1 of its ownK162067 VX130 Ophthalmic Diagnostic DeviceLuneau Sas · 2017
- Descendant · 3 generations on · 0 of its ownK202221 VX650Luneau Technology Operations · 2021
- Descendant · 2 generations on · 0 of its ownK201724 Pentacam AXL WaveOculus Optikgerate GmbH · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK181143 Keeler TonoCare TonometerKeeler Instruments, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K143086VX120 Ophthalmic Diagnostic DeviceLuneau Sas · 2015 · cites it directly3descendants
- K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas · 2017 · 2 generations on1descendant
- K202221VX650Luneau Technology Operations · 2021 · 3 generations on0descendants
- K201724Pentacam AXL WaveOculus Optikgerate GmbH · 2020 · 2 generations on0descendants
- K181143Keeler TonoCare TonometerKeeler Instruments, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990257 | Keeler Pulsair 3000 Non Contact Tonometer | Keeler Instruments, Inc. | 1999 | — |
| 0 (this device) | K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000 | Keeler Instruments, Inc. | 2010 | — |
| +1 | K143086 | VX120 Ophthalmic Diagnostic Device | Luneau Sas | 2015 | — |
| +2 | K162067 | VX130 Ophthalmic Diagnostic Device | Luneau Sas | 2017 | — |
| +3 | K202221 | VX650 | Luneau Technology Operations | 2021 | — |
| +2 | K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | 2020 | 2 |
| +1 | K181143 | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 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? (1)
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 |
|---|---|---|---|
| * | K990257 | Keeler Pulsair 3000 Non Contact TonometerSummary page 1…3. Predicate Device Description Predicate Device: Keeler Pulsair 3000 Non Contact Tonometer 51 0(k) Reference: K990257 Submission Approval Date: 251h March 1999 4. Device Description _____… | 1999 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K143086 (Luneau Sas, 2015) has gone furthest, with 3 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. 2010, this device’s year, is highlighted.
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?
The Pulsair IntelliPuff Non-Contact Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
The Pulsair Desktop Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093298 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093298: Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093298
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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