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Provider Site Prep & Check Strip Kit

by Pancretec, Inc.

510(k) K841027

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK841027 Date16 Apr 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Provider Site Prep and Check Strip Kit, classified under the product code FPA. It is designed for preparing and assessing skin sites prior to medical procedures, ensuring proper disinfection and readiness for interventions such as injections or infusions.

The kit is supplied as a single-use, non-sterile assembly intended for use in general hospital settings. It includes components for site preparation and verification, though specific sterility and MRI safety details are not provided in the regulatory data. Authorized under FDA 510(k) clearance (K841027), it adheres to traditional review standards and was classified as substantially equivalent to predicate devices in 1984.

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