Cleared Traditional

TARRY MEDICAL TEMPERATURE PROBES (K071977) - FDA 510(k) Clearance

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

K071977 · Tarry Medical Products, Inc. · General Hospital
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May 2008
Decision
311d
Days
Class 2
Risk

K071977 is an FDA 510(k) clearance for the TARRY MEDICAL TEMPERATURE PROBES. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Tarry Medical Products, Inc. (Shelton, US). The FDA issued a Cleared decision on May 23, 2008 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5400 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tarry Medical Products, Inc. devices

Submission Details

510(k) Number K071977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2007
Decision Date May 23, 2008
Days to Decision 311 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 129d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
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 Peers - FMZ Incubator, Neonatal

All 84
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