Cleared Traditional

K113813 - SENTRYSUITE PRODUCT LINE

K113813 is an FDA 510(k) clearance for SENTRYSUITE PRODUCT LINE, manufactured by Carefusion Germany 234 GmbH. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K113813 · Carefusion Germany 234 GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
139d
Days
Class 2
Risk

K113813 is an FDA 510(k) clearance for the SENTRYSUITE PRODUCT LINE. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Carefusion Germany 234 GmbH (Hoechberg, DE). The FDA issued a Cleared decision on May 10, 2012 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K113813

510(k) Number K113813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2011
Decision Date May 10, 2012
Days to Decision 139 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 140d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTY Calculator, Predicted Values, Pulmonary Function

All 43
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K113813.
Shape-HF Cardiopulmonary Testing System
K150888 · Shape Medical Systems, Inc. · Jan 2016
SENTRYSUITE PRODUCT LINE
K122699 · Carefusion Germany 234 GmbH · Nov 2012
EASYONE PRO RESPIRATORY TESTING DEVICE
K120635 · Ndd Medizitechnik AG · Sep 2012
SENTRYSUITE PRODUCT LINE
K111053 · Carefusion Germany 234 GmbH · Aug 2011
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
K091428 · Ndd Medizitechnik AG · Jan 2010
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
K090722 · Shape Medical Systems, Inc. · Mar 2009