510(k) Report

510(k) · Cleared

Cleared

Bioview Model S960000

K961056510(k) TraditionalCleared Jun 6, 199680-day reviewClass II21 CFR 876.1725

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

Sandhill Scientific, Inc. · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube

Cleared on Jun 6, 1996 after an 80-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 6, 1996
Review
80 days
Class
Class II
Product code
KLA
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2009: 1 descendant cleared2016: 1 descendant cleared1995200020052010201520202025
  1. This deviceK961056 Bioview Model S960000Sandhill Scientific, Inc. · 1996
  2. Descendant · cites it directly · 2 of its ownK984444 Insight Gastrointestinal Motility System, Model S980000Sandhill Scientific, Inc. · 1999
  3. Descendant · 2 generations on · 1 of its ownK091070 Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc. · 2009
  4. Descendant · 3 generations on · 0 of its ownK151086 ManoScan SystemGiven Imaging, Ltd. · 2016

Most influential descendants

Showing 3 of 3 · See all
  • K984444Insight Gastrointestinal Motility System, Model S980000Sandhill Scientific, Inc. · 1999 · cites it directly2descendants
  • K091070Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc. · 2009 · 2 generations on1descendant
  • K151086ManoScan SystemGiven Imaging, Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961056Bioview Model S960000Sandhill Scientific, Inc.1996—
+1K984444Insight Gastrointestinal Motility System, Model S980000Sandhill Scientific, Inc.1999—
+2K091070Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc.2009—
+3K151086ManoScan SystemGiven Imaging, Ltd.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200910
201610
FIG. 1 — Lineage of K961056, 1996–2016Source: 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 KLA? 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 KLA device

  1. #1 K242666 Fecobionics Anorectal Systemscore 10.3 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K984444Insight Gastrointestinal Motility System, Model S980000Sandhill Scientific, Inc.19992

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, K984444 (Sandhill Scientific, Inc., 1999) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KLA devices

KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLA

1in 2025

2007: 12012: 12015: 12017: 12018: 12024: 22025: 1
2007high 2 (2024) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLA

Too few KLA 510(k)s in any year since 2007 to give a median.

Recalls per year · KLA

No recall names KLA since 2007.

Adverse event reports per year · KLA

1in 2024

2015: 12017: 12018: 12020: 12023: 22024: 1
2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code KLA, 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
20071—00
20080—00
20090—00
20100—00
20110—00
20121—00
20130—00
20140—00
20151—01
20160—00
20171—01
20181—01
20190—00
20200—01
20210—00
20220—00
20230—02
20242—01
20251—00
20260—0—

More from Sandhill Scientific, Inc.

16 FDA decisions under this applicant name. See the company

  • K111013ACEMSandhill Scientific, Inc. · 2011
  • K012232Insight, Model S980000Sandhill Scientific, Inc. · 20022 recalls
  • K013951Sandhill Scientific Pediatec PH ProbeSandhill Scientific, Inc. · 2002
  • K002427Sandhill Unitip Catheter Pressure Sensor, Model K 5251-L3-0026Sandhill Scientific, Inc. · 2001
  • K990441Insight Sphincter of Oddi Manometry Module, Model S981300Sandhill Scientific, Inc. · 1999

Recent decisions in KLA

The KLA category page

  • K242666Fecobionics Anorectal SystemGi Bionics, LLC · 2025
  • K242304REDNeuraxis, Inc. · 2024
  • K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp. · 2024
  • K180135THD Anopress with THD SensyProbeThd Spa · 2018
  • K161785THD AnopressThd Spa · 2017

https://510kreport.com/device/K961056 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961056: Bioview Model S960000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961056

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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