Cleared Traditional

K981509 - TEMPO III

K981509 is an FDA 510(k) clearance for TEMPO III, manufactured by Medical Products, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K981509 · Medical Products, Inc. · General Hospital
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Jul 1998
Decision
73d
Days
Class 2
Risk

K981509 is an FDA 510(k) clearance for the TEMPO III. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Medical Products, Inc. (Chantilly, US). The FDA issued a Cleared decision on July 10, 1998 after a review of 73 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 Products, Inc. devices

FDA 510(k) Submission Details - K981509

510(k) Number K981509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1998
Decision Date July 10, 1998
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
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 28
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K981509.
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 AND TEMP H20
K973748 · Smith · Mar 1998
HEAT STACK
K980086 · Medical Solutions, Inc. · Mar 1998
INFUSION FLUID WARMER
K883873 · Pmt Corp. · Feb 1989