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ICU Saracap

by Ppg/Applied Resources, Inc.

510(k) K881093

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 NumberK881093 Date24 Jun 1988ClearedStatusActive

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  • Withdrawn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
CCK
Device Class
Class II
Regulation
21 CFR Part 868.1400
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The ICU Saracap is a cap for endotracheal tubes (Product Code CCK), designed to secure and stabilize the positioning of an endotracheal tube in the trachea during mechanical ventilation. It is intended to reduce the risk of accidental extubation by providing a secure, non-slip fit over the tube connector, ensuring patient safety in critical care settings.

This device is supplied as a single-use item and is regulated under FDA 510(k) clearance (K881093), with a decision date of June 24, 1988. It is intended for use in intensive care units (ICU) and is classified under the Anesthesiology advisory committee. No additional sterility or MRI safety information is specified in the regulatory data.

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