510(k) Report

510(k) · Cleared

Cleared

Sonomed 4000P Ultrasonic Pachymeter

K924311510(k) TraditionalCleared Dec 8, 1992104-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sonomed, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Dec 8, 1992 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Dec 8, 1992
Review
104 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2010: 2 descendants cleared2003: 1 descendant cleared2024: 1 descendant cleared2004: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK924311 Sonomed 4000P Ultrasonic PachymeterSonomed, Inc. · 1992
  2. Descendant · cites it directly · 7 of its ownK993674 Pocket Ultrasonic PachymeterQuantel Medical · 2000
  3. Descendant · 2 generations on · 3 of its ownK094038 Compact TouchQuantel S.A. · 2010
  4. Descendant · 3 generations on · 1 of its ownK180265 COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018
  5. Descendant · 2 generations on · 0 of its ownK232302 Pocket IIIQuantel Medical · 2024
  6. Descendant · 4 generations on · 0 of its ownK213254 Axialis Ophthalmic Ultrasound SystemQuantel Medical · 2021

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2000: 12003: 12004: 12010: 22018: 12021: 12024: 1
2000high 2 (2010) · low 0 (2001)2026

Most influential descendants

Showing 5 of 8 · See all
  • K993674Pocket Ultrasonic PachymeterQuantel Medical · 2000 · cites it directly7descendants
  • K094038Compact TouchQuantel S.A. · 2010 · 2 generations on3descendants
  • K180265COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018 · 3 generations on1descendant
  • K232302Pocket IIIQuantel Medical · 2024 · 2 generations on0descendants
  • K213254Axialis Ophthalmic Ultrasound SystemQuantel Medical · 2021 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924311Sonomed 4000P Ultrasonic PachymeterSonomed, Inc.1992—
+1K993674Pocket Ultrasonic PachymeterQuantel Medical2000—
+2K094038Compact TouchQuantel S.A.2010—
+3K180265COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical2018—
+2K232302Pocket IIIQuantel Medical2024—
+4K213254Axialis Ophthalmic Ultrasound SystemQuantel Medical2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200310
200410
201020
201810
202110
202410
FIG. 1 — Lineage of K924311, 1992–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993674Pocket Ultrasonic PachymeterQuantel Medical20007

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?

  • Of its descendants, K993674 (Quantel Medical, 2000) has gone furthest, with 7 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

More from Sonomed, Inc.

8 FDA decisions under this applicant name. See the company

  • K171098AXIS Image Management SystemSonomed, Inc. · 2017
  • K140199VUPADSonomed, Inc. · 2014
  • K100252Master-VU a-Scan, MV4500Sonomed, Inc. · 2010
  • K092637Pacscan Plus, Models 300P and 300APSonomed, Inc. · 2009
  • K073196Master-VUSonomed, Inc. · 2007

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https://510kreport.com/device/K924311 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924311: Sonomed 4000P Ultrasonic Pachymeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924311

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026