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INSUL-LINE

by Trademark Corp.

510(k) K911443

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 NumberK911443 Date26 Jul 1991ClearedStatusActive

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  • Withdrawn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, 28 Sep 2026

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

The INSUL-LINE is a device classified under product code FPA, with a substantially equivalent decision recorded under 510(k) number K911443. The device is associated with the applicant Trademark Corp., based in Fenton, MO, and was reviewed by the General Hospital advisory committee. Its regulatory history includes a decision date of July 26, 1991, and it falls under the traditional clearance type.

The INSUL-LINE device was submitted for FDA 510(k) review under the applicant Trademark Corp., with contact information listed for HARRY O TIGGARD at 1053 Headquarters Park, Fenton, MO 63026. The submission was received on April 1, 1991, and processed under the HO review advisory committee. No additional specifications on sterility, reusability, MRI safety, or storage are provided in the available data.