Cleared Traditional

K012276 - TEMP 3

K012276 is an FDA 510(k) clearance for TEMP 3, manufactured by Medical Solutions, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K012276 · Medical Solutions, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
32d
Days
Class 2
Risk

K012276 is an FDA 510(k) clearance for the TEMP 3. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Medical Solutions, Inc. (Chantilly, US). The FDA issued a Cleared decision on August 20, 2001 after a review of 32 days - a notably fast clearance cycle.

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

View all Medical Solutions, Inc. devices

FDA 510(k) Submission Details - K012276

510(k) Number K012276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2001
Decision Date August 20, 2001
Days to Decision 32 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGZ Device Classification - Class 2, Special Controls

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 Peers - LGZ Warmer, Thermal, Infusion Fluid

All 29
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K012276.
LARGE VOLUME FLUID RESERVOIR
K032778 · Belmont Instrument Corp. · Sep 2003
BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
K032674 · Belmont Instrument Corp. · Sep 2003
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · Nxstage Medical, Inc. · Oct 2001
TEMPO III
K981509 · Medical Products, Inc. · Jul 1998
TEMPO AND TEMP H20
K973748 · Smith · Mar 1998
HEAT STACK
K980086 · Medical Solutions, Inc. · Mar 1998