510(k) · Cleared
ClearedKeeler TonoCare 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 Feb 8, 2019 as substantially equivalent to K093298 (Keeler Instruments, Inc., 2010) after a 283-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Feb 8, 2019
- Review
- 283 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990257 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK990257 Keeler Pulsair 3000 Non Contact TonometerKeeler Instruments, Inc. · 1999
- 1 generation backK093298 Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000Keeler Instruments, Inc. · 2010
- This deviceK181143 Keeler TonoCare TonometerKeeler Instruments, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K181143 | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000Summary page 4…ULATION NUMBER: 886.1930 3. Predicate Device Description PRIMARY PREDICATE DEVICE: Keeler Pulsair IntelliPuff Tonometer 510(K) REFERENCE: K093298 SUBMISSION APPROVAL DATE: 10/12/2010 REFERENCE DEVICE: Accutome Tonometer 510(K) REFERENCE:… | 2010 |
| † | K083377 | Accupen | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 20 years and passes through 1 company; a new generation was cleared every 11.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K093298.
How does its category compare?
All HKX devicesHKX Tonometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Keeler TonoCare Tonometer is a hand-held, battery operated, non-contact tonometer intended to be used for measuring intraocular pressure (IOP) of the human eye with less than 3D in corneal astigmatism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181143: Keeler TonoCare Tonometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181143
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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