Cleared Traditional

K152946 - TEMPEDY

K152946 is an FDA 510(k) clearance for TEMPEDY, manufactured by Seiratherm GmbH. The device is a Class 2 Neurology device with product code NCX cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K152946 · Seiratherm GmbH · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
345d
Days
Class 2
Risk

K152946 is an FDA 510(k) clearance for the TEMPEDY. Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Seiratherm GmbH (91074 Herzogenaurach, DE). The FDA issued a Cleared decision on September 15, 2016 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.5900 - the FDA neurology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K152946

510(k) Number K152946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2015
Decision Date September 15, 2016
Days to Decision 345 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 149d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NCX Device Classification - Class 2, Special Controls

Product Code NCX System, Hypothermia, Intravenous, Cooling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
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 Neurology devices follow this clearance model.

Regulatory Consultant

Philosopher'S River, LLC
Mike Johnson

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 - NCX System, Hypothermia, Intravenous, Cooling

All 25
Devices cleared under the same product code (NCX) and FDA review panel - the closest regulatory comparables to K152946.
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K220008 · Zoll Circulation, Inc. · Jun 2022
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K153162 · Novocor Medical Systems, Inc. · May 2016
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K153226 · Zoll Circulation, Inc. · Mar 2016
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K150046 · Zoll Circulation, Inc. · Oct 2015
K152946 · TEMPEDY
Download PDF FDA Summary Seiratherm GmbH