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Sara Digicap

by Ppg/Applied Resources, Inc.

510(k) K874754

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 NumberK874754 Date21 Mar 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  • Withdrawn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, 26 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 Sara Digicap is a device classified under product code CCK, which corresponds to an anesthesia-related device type as indicated by the advisory committee description 'Anesthesiology'. It was granted a traditional 510(k) clearance by the FDA on March 21, 1988, under K874754, with a decision of substantially equivalent (SESE).

The device is manufactured by Ppg/Applied Resources, Inc. located in Lenexa, Kansas, United States. It is supplied as a non-sterile, reusable or single-use status is not specified in the data, and no information is provided regarding MRI safety, sizes, storage conditions, or clinical indications of use.

Other devices from Ppg/Applied Resources, Inc.

  • O.R. Saracap

    Class II

  • Sara Agie Monitor

    Class II

  • Saracap AG

    Class II

  • ICU Saracap

    Class II

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the SARA DIGICAP device used for?

    The SARA DIGICAP is classified under product code CCK and is described as an anesthesia-related device by the advisory committee. It is designed for use in anesthesiology settings, though specific clinical indications are not provided in the available data.

  • Is the SARA DIGICAP sterile and can it be reused?

    The SARA DIGICAP is supplied as a non-sterile device. However, the data does not specify whether it is intended for single-use or reusable purposes, so this information would need to be obtained directly from the manufacturer.

  • What regulatory approvals does the SARA DIGICAP have?

    The SARA DIGICAP received traditional 510(k) clearance from the FDA on March 21, 1988, under K874754, with a decision of substantially equivalent (SESE). It was reviewed by the AN advisory committee for anesthesiology devices.

  • Who manufactures the SARA DIGICAP and where is it produced?

    The SARA DIGICAP is manufactured by Ppg/Applied Resources, Inc., located at 9910 Widmer Dr., Lenexa, Kansas, United States. The contact person listed is JAMES F FERGUSON.