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The Perceptor(Tm) Stand Alone Transducer

by North American Instrument Corp.

510(k) K910764

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 NumberK910764 Date22 Apr 1991ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1429-2025 FDA Class II initiated 12 Feb 2025

    The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

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  • Withdrawn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
DRS
Device Class
Class II
Regulation
21 CFR Part 870.2850
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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