510(k) · Cleared
ClearedMD-2300S Ultrasonic A/B Scanner for Ophthalmology
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 Nov 17, 2015 as substantially equivalent to K051851 (Quantel Medical, 2005) and 1 other predicate after a 92-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Nov 17, 2015
- Review
- 92 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913067 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK913067 DGH-4000 a-Scan/PachymeterDgh Technology, Inc. · 1992
- 3 generations backK043287 Palmscan AP2000; Palmscan A2000; Palmscan P2000Micromedical Devices, Inc. · 2004
- 2 generations backK063472 Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100…Meda, Ltd. · 2007
- 1 generation backK121243 Ultrasonic Biometer for Ophthalmology Ultrasonic PachymeterMEDA Co., Ltd. · 2013
- This deviceK152318 MD-2300S Ultrasonic A/B Scanner for OphthalmologyMEDA Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913067 | DGH-4000 a-Scan/Pachymeter | Dgh Technology, Inc. | 1992 | — |
| −3 | K043287 | Palmscan AP2000; Palmscan A2000; Palmscan P2000 | Micromedical Devices, Inc. | 2004 | — |
| −2 | K063472 | Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200 | Meda, Ltd. | 2007 | — |
| −1 | K121243 | Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter | MEDA Co., Ltd. | 2013 | — |
| 0 (this device) | K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | MEDA Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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? (2)
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 |
|---|---|---|---|
| * | K051851 | Aviso Ophthalmic Ultrasound SystemSummary page 7…Manufacturer: Quantel Medical Inc. Trade Name: "Aviso" Ophthalmic Ultrasound System Common Name: Ophthalmic A and B scan ultrasound System 510(k) Number: K051851 Although "Aviso" Ophthalmic Ultrasound System has A-mode, it is “STD-A” A-scan 8MHz which is different from the A-mode… | 2005 |
| * | K121243 | Ultrasonic Biometer for Ophthalmology Ultrasonic PachymeterSummary page 7…ents have not undergone refractive surgery) Manufacturer: MEDA CO., LTD Device Name: MD-1000A Ultrasonic Biometer for Ophthalmology 510(k) Number: K121243 006-1 4. Device Description MD-2300S Ultrasonic A/B Scanner… | 2013 |
| † | K063433 | Ultrasonic Biometer/Pachymeter for Opthalmology Odm 2100 and Odm 2200 | 2007 |
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 23 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K051851.
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. 2015, 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?
MD-2300S Ultrasonic A/B Scanner for Ophthalmology is intended for ophthalmological ultrasonic diagnosis and AL biometric measurement. The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure. The device should be operated by trained medical staff. Patients with eyelid trauma and severe eye infection are prohibited from using B-Scan; and…
Read the full statement (104 words)
MD-2300S Ultrasonic A/B Scanner for Ophthalmology is intended for ophthalmological ultrasonic diagnosis and AL biometric measurement.
The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure.
The device should be operated by trained medical staff.
Patients with eyelid trauma and severe eye infection are prohibited from using B-Scan; and patients with keratitis and cornea trauma are prohibited from using A-Biometric scan.
The A-biometric scan should be used cautiously on patients without independent behavior abilities or who are highly sensitive to contacting measurements, whose ineffective cooperation may result in inaccurate measurements.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152318: MD-2300S Ultrasonic A/B Scanner for Ophthalmology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152318
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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