510(k) · Cleared
ClearedPalmscan AP2000; Palmscan A2000; Palmscan P2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedical Devices, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 10, 2004 as substantially equivalent to K913067 (Dgh Technology, Inc., 1992) after an 11-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Dec 10, 2004
- Review
- 11 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913067 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK913067 DGH-4000 a-Scan/PachymeterDgh Technology, Inc. · 1992
- This deviceK043287 Palmscan AP2000; Palmscan A2000; Palmscan P2000Micromedical Devices, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK063472 Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100…Meda, Ltd. · 2007
- Descendant · 2 generations on · 1 of its ownK121243 Ultrasonic Biometer for Ophthalmology Ultrasonic PachymeterMEDA Co., Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK152318 MD-2300S Ultrasonic A/B Scanner for OphthalmologyMEDA Co., Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K063472Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200Meda, Ltd. · 2007 · cites it directly2descendants
- K121243Ultrasonic Biometer for Ophthalmology Ultrasonic PachymeterMEDA Co., Ltd. · 2013 · 2 generations on1descendant
- K152318MD-2300S Ultrasonic A/B Scanner for OphthalmologyMEDA Co., Ltd. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913067 | DGH-4000 a-Scan/Pachymeter | Dgh Technology, Inc. | 1992 | — |
| 0 (this device) | K043287 | Palmscan AP2000; Palmscan A2000; Palmscan P2000 | Micromedical Devices, Inc. | 2004 | — |
| +1 | K063472 | Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200 | Meda, Ltd. | 2007 | — |
| +2 | K121243 | Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter | MEDA Co., Ltd. | 2013 | — |
| +3 | K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | MEDA Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 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.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063472 | Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200 | 2007 | 2 |
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 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?
Collectively, the 3 PalmScan 2000 Devices [i.e., three (3) biometric devices listed below] are each designed as either: a) the PalmScan AP2000 A-Scan/Pachymeter Combination dual mode device [i.e., PalmScan AP2000]; or solely as: b) the PalmScan A2000 A-Scan mode only device [i.e., PalmScan A2000]; or as: c) the PalmScan P2000 Pachymeter mode only [i.e., PalmScan P2000] medical device. The PalmScan AP2000 A-Scan/Pachymeter Combination [i.e., PalmScan…
Read the full statement (306 words)
Collectively, the 3 PalmScan 2000 Devices [i.e., three (3) biometric devices listed below] are each designed as either: a) the PalmScan AP2000 A-Scan/Pachymeter Combination dual mode device [i.e., PalmScan AP2000]; or solely as: b) the PalmScan A2000 A-Scan mode only device [i.e., PalmScan A2000]; or as: c) the PalmScan P2000 Pachymeter mode only [i.e., PalmScan P2000] medical device.
The PalmScan AP2000 A-Scan/Pachymeter Combination [i.e., PalmScan AP2000] device is intended as a portable battery operated biometer, which incorporates A-mode pulsed-echo ultrasound technology, and thus is intended be used to accurately measure the axial length (AL), anterior chamber depth (ACD), lens thickness (LT), and corneal thickness (CT) of the human eye. This PalmScan AP2000 device is also intended for calculating the optical power of an intraocular lens (IOL) that is to be implanted during cataract surgery.
The PalmScan A2000 A-Scan [i.e., PalmScan A2000] device is intended as a portable battery operated biometer, which incorporates A-mode pulsed-echo ultrasound technology, and thus is intended be used to accurately measure the axial length (AL), anterior chamber depth (ACD), and lens thickness (LT) of the human eye. This PalmScan A2000 device is also intended for calculating the optical power of an intraocular lens (IOL) that is to be implanted during cataract surgery.
The PalmScan P2000 Pachymeter [i.e., PalmScan P2000] device (as well as the combination PalmScan AP2000 device) is intended as a potable battery operated pachymeter, which incorporates A-mode pulsed-echo ultrasound technology, and thus is intended be used to accurately measure the comeal thickness (CT) of the human eye.
Each of the 3 PalmScan 2000 Devices [i.e., PalmScan AP2000 combination device; PalmScan A2000 A-Scan device; and/or PalmScan P2000 pachymeter device] is intended to be used solely by qualified medical professionals. Clinical considerations and professional judgment should be applied when using this or any other testing device used for patient diagnosis or treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043287: Palmscan AP2000; Palmscan A2000; Palmscan P2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043287
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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