510(k) · Cleared
ClearedUltrasonic Biometer for Ophthalmology Ultrasonic Pachymeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MEDA Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 3, 2013 as substantially equivalent to K063472 (Meda, Ltd., 2007) after a 373-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- May 3, 2013
- Review
- 373 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K913067 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK913067 DGH-4000 a-Scan/PachymeterDgh Technology, Inc. · 1992
- 2 generations backK043287 Palmscan AP2000; Palmscan A2000; Palmscan P2000Micromedical Devices, Inc. · 2004
- 1 generation backK063472 Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100…Meda, Ltd. · 2007
- This deviceK121243 Ultrasonic Biometer for Ophthalmology Ultrasonic PachymeterMEDA Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK152318 MD-2300S Ultrasonic A/B Scanner for OphthalmologyMEDA Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K152318MD-2300S Ultrasonic A/B Scanner for OphthalmologyMEDA Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913067 | DGH-4000 a-Scan/Pachymeter | Dgh Technology, Inc. | 1992 | — |
| −2 | 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 | — |
| 0 (this device) | K121243 | Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter | MEDA Co., Ltd. | 2013 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K063472 | Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200Summary page 1…acturer: MEDA Co., Ltd Device: ODM-1000A/P Biometer ODM-1000A Ultrasonic A-Biometer 0DM-i1OOOP Ultrasonic Pachymeter 510(k) Number: K063472 4. Device Description The MD-100O Series of Ultrasonic Biometer/Pachymeter for Ophthalmology consists of three… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | 2015 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K152318 (MEDA Co., Ltd., 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. 2013, this device’s year, is highlighted.
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 MD-1000A/P is used for ophthalmology to measure axial length (AL), anterior chamber depth (ACD), lens thickness (LT), and corneal thickness (CT).
The MD-1000A is used for ophthalmology to measure axial length (AL), anterior chamber depth (ACD) and lens thickness (LT).
The MD-i OQOP is used for ophthalmology to measure comneal thickness (CT).
The device should be operated by trained doctors. It should be used cautiously to patients without independent behavior abilities. Cornea trauma or inflammation patients are prohibited to use the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121243: Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121243
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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