Cleared Traditional

K202461 - ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202461 · Smisson-Cartledge Biomedical, LLC · General Hospital
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Aug 2022
Decision
715d
Days
Class 2
Risk

K202461 is an FDA 510(k) clearance for the ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion .... Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Smisson-Cartledge Biomedical, LLC (Macon, US). The FDA issued a Cleared decision on August 12, 2022 after a review of 715 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Smisson-Cartledge Biomedical, LLC devices

Submission Details

510(k) Number K202461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2020
Decision Date August 12, 2022
Days to Decision 715 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
587d slower than avg
Panel avg: 128d · This submission: 715d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGZ Warmer, Thermal, Infusion Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Regulatory Resources Group, Inc.
Julie Stephens

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.

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All 74
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