510(k) Report

510(k) · Cleared

Cleared

Sharplan Usight 9010 Laparoscopic Ultrasound System

K945796510(k) TraditionalCleared May 24, 1995177-day reviewClass II21 CFR 892.1570

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

Sharplan Lasers, Inc. · ITX Transducer, Ultrasonic, Diagnostic

Cleared on May 24, 1995 after a 177-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
May 24, 1995
Review
177 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
0

5 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1996: 1 descendant cleared1998: 2 descendants cleared1995200020052010201520202025
  1. This deviceK945796 Sharplan Usight 9010 Laparoscopic Ultrasound SystemSharplan Lasers, Inc. · 1995
  2. Descendant · cites it directly · 2 of its ownK972973 Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997
  3. Descendant · cites it directly · 1 of its ownK972192 Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc. · 1997
  4. Descendant · 2 generations on · 0 of its ownK981834 Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998
  5. Descendant · 2 generations on · 0 of its ownK974880 Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc. · 1998
  6. Descendant · cites it directly · 0 of its ownK955327 HP Sonos 100CF Ultrasound Imaging SystemHewlett-Packard Co. · 1996

Most influential descendants

Showing 5 of 5 · See all
  • K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997 · cites it directly2descendants
  • K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc. · 1997 · cites it directly1descendant
  • K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998 · 2 generations on0descendants
  • K974880Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc. · 1998 · 2 generations on0descendants
  • K955327HP Sonos 100CF Ultrasound Imaging SystemHewlett-Packard Co. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945796Sharplan Usight 9010 Laparoscopic Ultrasound SystemSharplan Lasers, Inc.1995—
+1K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc.1997—
+1K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc.1997—
+2K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc.1998—
+2K974880Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc.1998—
+1K955327HP Sonos 100CF Ultrasound Imaging SystemHewlett-Packard Co.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199720
199820
FIG. 1 — Lineage of K945796, 1995–1998Source: 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 ITX? 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 ITX device

  1. #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc.19972
K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc.19971
K955327HP Sonos 100CF Ultrasound Imaging SystemHewlett-Packard Co.19960

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, K972973 (Perception, Inc., 1997) has gone furthest, with 2 descendants of its own.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITX

4in 2025

2007: 102008: 122009: 172010: 102011: 102012: 72013: 32014: 42015: 12016: 42017: 62018: 22019: 12020: 32021: 32022: 22023: 62024: 32025: 42026 (partial year): 6
2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007: 26 days median2008: 73 days median2009: 28 days median2010: 42 days median2011: 16 days median2012: 25 days median2013: 105 days median2014: 41 days median2016: 151 days median2017: 110 days median2020: 120 days median2021: 139 days median2023: 213 days median2024: 81 days median2025: 126 days median2026 (partial year): 158 days median
2007high 213 (2023) · low 16 (2011)2026

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

Recalls per year · ITX

2in 2025

2008: 42009: 42010: 42011: 12012: 12014: 12015: 52017: 12018: 152020: 32021: 10, 10 Class I2022: 62023: 12024: 12025: 2
2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007: 162008: 392009: 232010: 302011: 342012: 292013: 382014: 432015: 1832016: 2692017: 4122018: 1302019: 1192020: 1162021: 1462022: 872023: 1382024: 9882025: 571
2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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
20071026016
20081273439
20091728423
20101042430
20111016134
2012725129
20133105038
2014441143
20151—5183
201641510269
201761101412
20182—15130
20191—0119
202031203116
2021313910 (10)146
20222—687
202362131138
20243811988
202541262571
202661580—

More from Sharplan Lasers, Inc.

78 FDA decisions under this applicant name. See the company

  • K973354Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
  • K972099Sharplan Epitouch Ruby Laser SystemSharplan Lasers, Inc. · 1997
  • K971874Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
  • K971648Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc. · 1997
  • K971743Sharplan CO2 Surgical Laser SystemSharplan Lasers, Inc. · 1997

Recent decisions in ITX

The ITX category page

  • K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
  • K261170BA-004CCFujifilm Corporation · 2026
  • K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026
  • K260161SmartGuide Disposable Guides and GridsUC-CARE, Ltd. · 2026
  • K262474ND Needle Guidance SystemAccurate Access, LLC · 2026

https://510kreport.com/device/K945796 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945796: Sharplan Usight 9010 Laparoscopic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945796

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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