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Insight, Model S980000

by Sandhill Scientific, Inc.

510(k) K012232

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012232 Date7 Jun 2002ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2521-2023 FDA Class III initiated 25 Jul 2023

    GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

    • Terminated Z-1487-2012 FDA Unclassified (pre-2012) initiated 23 Feb 2009

    Software error may produce incorrect esophageal contraction readings.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FFX
Device Class
Class II
Regulation
21 CFR Part 876.1725
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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