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Sentrysuite Product Line

by Carefusion Germany 234 GmbH 3 variants

510(k) K111053

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111053 Date12 Aug 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
BTY
Device Class
Class II
Regulation
21 CFR Part 868.1890
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Sentrysuite Product Line is a calculator for pulmonary function, predicted values, classified under device class 2. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway.

The device was manufactured by Carefusion Germany 234 GmbH, received FDA clearance on August 12, 2011 under K-number K111053, and is associated with product code BTY and regulation number 868.1890. It is used in the anesthesiology specialty and has no indicated sterility, single-use status, MRI safety, sizes, or storage requirements in the provided data.

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