Cleared Traditional

K151461 - Hybernite RT

K151461 is an FDA 510(k) clearance for Hybernite RT, manufactured by Plastiflex Group NV. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K151461 · Plastiflex Group NV · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
297d
Days
Class 2
Risk

K151461 is an FDA 510(k) clearance for the Hybernite RT. Classified as Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer within the BZE classification (a category for neonatal and pediatric respiratory circuit components), Class II - Special Controls.

Submitted by Plastiflex Group NV (Paal-Beringen, BE). The FDA issued a Cleared decision on March 24, 2016 after a review of 297 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5270 - 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. Neonatal respiratory circuit components typically face extended FDA review due to heightened safety scrutiny for pediatric patient populations - the 176-day cycle reflects this additional regulatory diligence.

FDA 510(k) Submission Details - K151461

510(k) Number K151461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2015
Decision Date March 24, 2016
Days to Decision 297 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
157d slower than avg
Panel avg: 140d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZE Device Classification - Class 2, Special Controls

Product Code BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5270
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 Consultant

Qserve Group, Us, Inc.
Patsy J Trisler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

All 34
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K151461.
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Flexicare Heated Wire Breathing Systems
K150900 · Flexicare Medical, Ltd. · May 2015