510(k) · Cleared
ClearedAccupach V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accutome Ultrasound, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 10, 2004 as substantially equivalent to K810660 (Accutome, Inc., 1981) after a 37-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.
- Decided
- Nov 10, 2004
- Review
- 37 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K810660 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK810660 Kremer Corneometer Ultrasonic PachometerAccutome, Inc. · 1981
- This deviceK042752 Accupach VAccutome Ultrasound, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK152573 4SightAccutome, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK050552 Pachpen Pachymeter, Model 24-5100Accutome, Inc. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810660 | Kremer Corneometer Ultrasonic Pachometer | Accutome, Inc. | 1981 | — |
| 0 (this device) | K042752 | Accupach V | Accutome Ultrasound, Inc. | 2004 | — |
| +1 | K152573 | 4Sight | Accutome, Inc. | 2015 | — |
| +1 | K050552 | Pachpen Pachymeter, Model 24-5100 | Accutome, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2015 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K810660 | Kremer Corneometer Ultrasonic PachometerSummary page 1…ing, Pulsed Echo, Ultrasonic (see: 21 CFR 892.1560) Product Code: IYO Panel: 90 Legally Marketed Accutome Kremer Corneometer (KS810660) Predicate Devices: Description of the Device: The AccuPach V device is designed as an ultrasound… | 1981 |
What descends from it? (2)
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, K152573 (Accutome, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The instrument is used for measuring the corneal thickness of the eye, and calculating a corrected intraocular pressure based on those measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042752: Accupach V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042752
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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