Cleared Traditional

K122699 - SENTRYSUITE PRODUCT LINE

K122699 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 76-day FDA review.

K122699 · Carefusion Germany 234 GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
76d
Days
Class 2
Risk

K122699 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 November 19, 2012 after a review of 76 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K122699

510(k) Number K122699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2012
Decision Date November 19, 2012
Days to Decision 76 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
64d faster than avg
Panel avg: 140d · This submission: 76d
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 K122699.
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EASYONE PRO RESPIRATORY TESTING DEVICE
K120635 · Ndd Medizitechnik AG · Sep 2012
SENTRYSUITE PRODUCT LINE
K113813 · Carefusion Germany 234 GmbH · May 2012
SENTRYSUITE PRODUCT LINE
K111053 · Carefusion Germany 234 GmbH · Aug 2011